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[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 1368 Introduced in Senate (IS)]

105th CONGRESS
  1st Session
                                S. 1368

To provide individuals with access to health information of which they 
   are the subject, ensure personal privacy with respect to personal 
 medical records and health care-related information, impose criminal 
      and civil penalties for unauthorized use of personal health 
information, and to provide for the strong enforcement of these rights.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            November 4, 1997

Mr. Leahy (for himself and Mr. Kennedy) introduced the following bill; 
 which was read twice and referred to the Committee on Labor and Human 
                               Resources

_______________________________________________________________________

                                 A BILL

 
To provide individuals with access to health information of which they 
   are the subject, ensure personal privacy with respect to personal 
 medical records and health care-related information, impose criminal 
      and civil penalties for unauthorized use of personal health 
information, and to provide for the strong enforcement of these rights.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Medical 
Information Privacy and Security Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Purposes.
Sec. 4. Definitions.
                      TITLE I--INDIVIDUAL'S RIGHTS

 Subtitle A--Access to Protected Health Information by Subjects of the 
                              Information

Sec. 101. Inspection and copying of protected health information.
Sec. 102. Supplements to protected health information.
Sec. 103. Notice of privacy practices.
                Subtitle B--Establishment of Safeguards

Sec. 111. Establishment of safeguards.
Sec. 112. Accounting for disclosures.
              TITLE II--RESTRICTIONS ON USE AND DISCLOSURE

                    Subtitle A--General Restriction

Sec. 201. General rule regarding use and disclosure.
Sec. 202. Authorizations for disclosure of protected health 
                            information.
  Subtitle B--Limited Circumstances Providing for Disclosure Without 
                             Authorization

Sec. 211. Emergency circumstances.
Sec. 212. Public health.
Sec. 213. Protection and advocacy agencies.
Sec. 214. Oversight.
Sec. 215. Disclosure for law enforcement purposes.
             Subtitle C--Special Rules Governing Disclosure

Sec. 221. Next of kin and directory information.
Sec. 222. Health research.
Sec. 223. Judicial and administrative purposes.
Sec. 224. Individual representatives.
Sec. 225. Prohibition against retaliation.
 TITLE III--OFFICE OF HEALTH INFORMATION PRIVACY OF THE DEPARTMENT OF 
                       HEALTH AND HUMAN SERVICES

                       Subtitle A--Establishment

Sec. 301. Establishment.
                        Subtitle B--Enforcement

                     CHAPTER 1--Criminal Provisions

Sec. 311. Wrongful disclosure of protected health information.
Sec. 312. Debarment for crimes.
                       CHAPTER 2--Civil Sanctions

Sec. 321. Civil penalty.
Sec. 322. Procedures for imposition of penalties.
Sec. 323. Civil action by individuals.
                        TITLE IV--MISCELLANEOUS

Sec. 401. Relationship to other laws.
Sec. 402. Effective date.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) individuals have a right of privacy with respect to 
        their personal medical information and records;
            (2) with respect to information about medical care and 
        health status, the traditional right of confidentiality 
        (between a health care provider and a patient) is at risk;
            (3) an erosion of the right of privacy may reduce the 
        willingness of patients to confide in physicians and other 
        practitioners and may inhibit such patients from seeking care;
            (4) the use of electronic medical records offers many 
        potential advantages compared to traditional paper-based 
        systems if encompassed with strong privacy safeguards, through 
        the sharing and linking of medical records electronically which 
        can reduce costs, improve efficiencies and enhance medical care 
        while helping to avoid duplicate tests, prevent fraud and 
        protect against unintended dangerous drug interactions;
            (5) the European Union has adopted a directive that 
        provides that electronic medical records can not be sent from 
        Union member nations to other nations, such as the United 
        States, unless the non-member country assures the security and 
        confidentiality of medical records under its national laws and 
        practices;
            (6) an individual's privacy right means that the 
        individual's consent is needed to disclose his or her 
        personally identifiable health information and that the 
        individual has a right of access to that health information;
            (7) any disclosure of personally identifiable health 
        information should be limited to that information or portion of 
        the medical record necessary to fulfill the immediate and 
        specific purpose of the disclosure;
            (8) an individual's health information is currently 
        accessible to many people who do not need the information to 
        provide health care to the individual, often without the 
        individual's knowledge or consent;
            (9) in the report of the National Research Council of 
        March, 1997, the Council concluded that--
                    (A) with respect to the protection of electronic 
                medical records, ``few penalties exist for lax 
                security'' and that ``few controls exist to prevent 
                such information from being used in ways that could 
                harm patients or invade their privacy'';
                    (B) ``patients have little control over the ways in 
                which information about their health is collected, 
                used, or disseminated'';
                    (C) ``[t]he greatest concerns regarding patient 
                privacy stem from the widespread dissemination of 
                information throughout the health care industry and 
                related industries, often without the knowledge or 
                consent of the patients . . . [i]n many cases, this 
                information can be used in ways that are perceived as 
                detrimental to patient privacy and contrary to the 
                interests of patients. . . .'';
                    (D) consent to release medical information should 
                be for specified information and purposes and for 
                limited amounts of time after which the medical 
                provider ``must obtain new authorization from the 
                patient'';
                    (E) ``health care providers should give patients 
                the right to request audits of all access to their 
                electronic medical records and to review such logs'';
                    (F) with respect to the use of the social security 
                number as a universal patient identifier, the ``use of 
                the social security number raises many legitimate 
                privacy concerns''; and
                    (G) a national office of privacy should be 
                established since ``consumers need a mechanism for 
                learning about their rights and how they may seek 
                recourse for violations of fair information practices, 
                and they need to be protected from the possibility that 
                their access to care may be jeopardized by exercising 
                their established privacy rights'';
            (10) medical research often depends on access to both 
        identifiable and nonidentifiable patient medical records and 
        medical research is critically important to the health and 
        well-being of all Americans;
            (11) currently, there is technology available which can 
        ease the process by which identifiable data can be stripped of 
        all patient identifiers to support the necessary balance 
        between medical research and privacy protections for 
        individuals;
            (12) the American Medical Association Council on Ethical 
        Affairs has concluded that--
                    (A) a patient and a physician ``should be advised 
                about the existence of computerized data bases in which 
                medical information concerning the patient is stored'';
                    (B) information regarding the existence of 
                computerized data bases ``should be communicated to the 
                physician and patient prior to the physician's release 
                of the medical information to the entity or entities 
                maintaining the computer data bases'';
                    (C) a physician and patient ``should be notified of 
                the distribution of all reports reflecting identifiable 
                patient data prior to distribution of the reports by 
                the computer facility''; and
                    (D) there should be ``approval by the patient and 
                notification of the physician prior to the release of 
                patient-identifiable clinical and administrative data 
                to individuals or organizations external to the medical 
                care environment'';
            (13)(A) genetic information contains the uniquely private 
        and personal genetic information of an individual which is 
        rapidly being deciphered and understood; and
            (B) research in genetics continues to provide immense 
        health benefits to individuals and their families, however, the 
        improper use and unauthorized disclosure of genetic information 
        may cause significant social and psychological harm to 
        individuals, including stigmatization and discrimination;
            (14) the Supreme Court found in Jaffee v. Redmond (116 
        S.Ct. 1923 (1996)) that--
                    (A) there is an imperative need for confidence and 
                trust between a psychotherapist and a patient;
                    (B) this trust can only be established by an 
                assurance of confidentiality; and
                    (C) preservation of such trust and confidentiality 
                serves the public interest by facilitating the 
                provision of appropriate treatment for individuals; and
            (15) section 264 of the Health Insurance Portability and 
        Accountability Act of 1996 (42 U.S.C. 1320d-2 note) establishes 
        a deadline that Congress enact legislation, within 36 months 
        after the date of enactment of such Act, to protect the privacy 
        of personal health information.

SEC. 3. PURPOSES.

    It is the purpose of this Act to--
            (1) recognize that there is a right to privacy with respect 
        to health information, including genetic information, and that 
        this right must be protected;
            (2) establish an Office of Health Information Privacy 
        within the Department of Health and Human Services to protect 
        that right of privacy;
            (3) provide individuals with--
                    (A) access to health information of which they are 
                the subject; and
                    (B) the opportunity to challenge the accuracy and 
                completeness of such information by being able to file 
                supplements of such records;
            (4) provide individuals with the right to limit the use and 
        disclosure of personally identifiable health information;
            (5) create incentives to turn personal health information 
        into nonidentifiable health information for oversight, health 
        research, public health, law enforcement, judicial, and 
        administrative purposes;
            (6) establish strong and effective mechanisms to protect 
        against the unauthorized and inappropriate use of personally 
        identifiable health information that is created or maintained 
        as part of health care treatment, diagnosis, enrollment, 
        payment, plan administration, testing, or research processes;
            (7) invoke the sweep of congressional powers, including the 
        power to enforce the 14th amendment, to regulate commerce, and 
        to abrogate the immunity of the States under the 11th 
        amendment, in order to address violations of the rights of 
        individuals to privacy, to provide access to their medical 
        records, and to prevent unauthorized use of personal genetic 
        information; and
            (8) establish strong and effective remedies for violations 
        of this Act.

SEC. 4. DEFINITIONS.

    In this Act:
            (1) Administrative billing information.--The term 
        ``administrative billing information'' means any of the 
        following forms of protected health information:
                    (A) Date of service, policy, patient and 
                practitioner or facility identifiers.
                    (B) Diagnostic codes, in accordance with medicare 
                billing codes, for which treatment is being rendered or 
                requested.
                    (C) Complexity of service codes, indicating 
                duration of treatment.
                    (D) Total billed charges.
            (2) Agent.--The term ``agent'' means a person who 
        represents and acts for another under the contract or relation 
        of agency, or whose function is to bring about, modify, affect, 
        accept performance of, or terminate contractual obligations 
        between the principal and a third person, and includes the 
        employees of such persons.
            (3) Disclose.--The term ``disclose'' means to release, 
        transfer, permit access to, or otherwise divulge protected 
        health information to any person other than the individual who 
        is the subject of such information. Such term includes the 
        initial disclosure and any subsequent redisclosures of 
        individually identifiable health care information.
            (4) Employer.--The term ``employer'' means a person engaged 
        in business affecting commerce who has employees.
            (5) Health care.--The term ``health care'' means--
                    (A) preventive, diagnostic, therapeutic, 
                rehabilitative, maintenance, or palliative care, 
                including appropriate assistance with disease or 
                symptom management and maintenance, counseling, 
                service, or procedure--
                            (i) with respect to the physical or mental 
                        condition of an individual; or
                            (ii) affecting the structure or function of 
                        the human body or any part of the human body, 
                        including the banking of blood, sperm, organs, 
                        or any other tissue; and
                    (B) any sale or dispensing of a drug, device, 
                equipment, or other health care related item to an 
                individual, or for the use of an individual, pursuant 
                to a prescription.
            (6) Health care provider.--The term ``health care 
        provider'' means a person, who with respect to a specific item 
        of protected health information, receives, creates, uses, 
        maintains, or discloses the information while acting in whole 
        or in part in the capacity of--
                    (A) a person who is licensed, certified, 
                registered, or otherwise authorized by Federal or State 
                law to provide an item or service that constitutes 
                health care in the ordinary course of business, or 
                practice of a profession;
                    (B) a Federal or State program that directly 
                provides items or services that constitute health care 
                to beneficiaries; or
                    (C) an officer or employee of a person described in 
                subparagraph (A) or (B) that is engaged in the 
                provision of health care.
            (7) Health or life insurer.--The term ``health or life 
        insurer'' means a health insurance issuer as defined in section 
        9805(b)(2) of the Internal Revenue Code of 1986 or a life 
        insurance company as defined in section 816 of such Code and 
        includes the employees of such person.
            (8) Health oversight agency.--The term ``health oversight 
        agency'' means a person who--
                    (A) performs or oversees the performance of an 
                assessment, investigation, or prosecution relating to 
                compliance with legal or fiscal standards relating to 
                health care fraud or fraudulent claims regarding health 
                care, health services or equipment, or related 
                activities and items; and
                    (B) is a public executive branch agency, acting on 
                behalf of a public executive branch agency, acting 
                pursuant to a requirement of a public executive branch 
                agency, or carrying out activities under a Federal or 
                State law governing the assessment, evaluation, 
                determination, investigation, or prosecution described 
                in subparagraph (A) and includes the employees of such 
                person.
            (9) Health plan.--The term ``health plan'' means any health 
        insurance plan, including any hospital or medical service plan, 
        dental or other health service plan or health maintenance 
        organization plan, or other program providing or arranging for 
        the provision of health benefits, whether or not funded through 
        the purchase of insurance. Such term includes employee welfare 
        benefit plans and group plans as such plans are defined in 
        sections 3 and 607 of the Employee Retirement Income Security 
        Act of 1974 (29 U.S.C. 1002 and 1167).
            (10) Health researcher.--The term ``health researcher'' 
        means a person who, with respect to a specific item of 
        protected health information, receives the information--
                    (A) pursuant to section 222 (relating to health 
                research); or
                    (B) while acting in whole or in part in the 
                capacity of an officer or employee or agent of a person 
                who receives the information described in subparagraph 
                (A).
            (11) Law enforcement inquiry.--The term ``law enforcement 
        inquiry'' means a lawful executive branch investigation or 
        official proceeding inquiring into a violation of, or failure 
        to comply with, any criminal or civil statute or any 
        regulation, rule, or order issued pursuant to such a statute.
            (12) Nonidentifiable health information.--The term 
        ``nonidentifiable health information'' means any information 
        that would otherwise be protected health information except 
        that is does not reveal the identity of the individual whose 
        health or health care is the subject of the information and 
        there is no reasonable basis to believe that the information 
        could be used to identify that individual.
            (13) Office of health information privacy.--The term 
        ``Office of Health Information Privacy'' means the Office of 
        Health Information Privacy established under section 301.
            (14) Person.--The term ``person'' means a government, 
        governmental subdivision of an executive branch agency or 
        authority; corporation; company; association; firm; 
        partnership; society; estate; trust; joint venture; individual; 
        individual representative; tribal government; and any other 
        legal entity.
            (15) Protected health information.--The term ``protected 
        health information'' means any information, including genetic 
        information, demographic information, and tissue samples 
        collected from an individual, whether oral or recorded in any 
        form or medium, that--
                    (A) is created or received by a health care 
                provider, health researcher, health plan, health 
                oversight agency, public health authority, employer, 
                health or life insurer, school or university; and
                    (B)(i) relates to the past, present, or future 
                physical or mental health or condition of an individual 
                (including individual cells and their components), the 
                provision of health care to an individual, or the past, 
                present, or future payment for the provision of health 
                care to an individual; and
                    (ii)(I) identifies an individual; or
                    (II) with respect to which there is a reasonable 
                basis to believe that the information can be used to 
                identify an individual.
            (16) Public health authority.--The term ``public health 
        authority'' means an authority or instrumentality of the United 
        States, a tribal government, a State, or a political 
        subdivision of a State that is--
                    (A) primarily responsible for public health 
                matters; and
                    (B) primarily engaged in activities such as injury 
                reporting, public health surveillance, and public 
                health investigation or intervention.
            (17) School or university.--The term ``school or 
        university'' means an institution or place for instruction or 
        education, including an elementary school, secondary school, or 
        institution of higher learning, a college, or an assemblage of 
        colleges united under one corporate organization or government.
            (18) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (19) State.--The term ``State'' includes the District of 
        Columbia, Puerto Rico, the Virgin Islands, Guam, American 
        Samoa, and the Northern Mariana Islands.
            (20) Writing.--The term ``writing'' means writing in either 
        a paper-based or computer-based form, including electronic 
        signatures.

                      TITLE I--INDIVIDUAL'S RIGHTS

 Subtitle A--Access to Protected Health Information by Subjects of the 
                              Information

SEC. 101. INSPECTION AND COPYING OF PROTECTED HEALTH INFORMATION.

    (a) Right of Individual.--
            (1) In general.--A health care provider, health researcher, 
        health plan, employer, health or life insurer, school, or 
        university, or the agent of any such individual or entity, 
        shall permit an individual who is the subject of protected 
        health information, or the individual's designee, to inspect 
        and copy protected health information concerning the 
        individual, including records created under sections 102 and 
        112, that such entity maintains.
            (2) Procedures and fees.--An entity described in paragraph 
        (1) may set forth appropriate procedures to be followed for 
        inspection and copying under such paragraph and may require an 
        individual to pay fees associated with such inspection and 
        copying in an amount that is not in excess of the actual costs 
        of providing such copying. Such fees may not be assessed where 
        such an assessment would have the effect of prohibiting an 
        individual from gaining access to the information involved.
    (b) Deadline.--An entity described in subsection (a) shall comply 
with a request for inspection or copying of protected health 
information under this section not later than 15 business days after 
the date on which the entity receives the request.
    (c) Rules Governing Agents.--An agent of an entity described in 
subsection (a) shall provide for the inspection and copying of 
protected health information if--
            (1) the protected health information is retained by the 
        agent; and
            (2) the agent has been asked by the entity involved to 
        fulfill the requirements of this section.

SEC. 102. SUPPLEMENTS TO PROTECTED HEALTH INFORMATION.

    (a) In General.--Not later than 45 days after the date on which a 
health care provider, health researcher, health plan, employer, health 
or life insurer, school, or university, or the agent of any such 
individual or entity, receives from an individual a request in writing 
to supplement information, such entity shall--
            (1) add the supplement requested to the records;
            (2) inform the individual of the supplement that has been 
        added; and
            (3) make reasonable efforts to inform any person to whom 
        the portion of the unsupplemented information was previously 
        disclosed, of any nontechnical supplement that has been made.
    (b) Refusal to Supplement.--If an entity described in subsection 
(a) declines to make the supplement requested under such subsection, 
the entity shall inform the individual in writing of--
            (1) the reasons for declining to make the supplement;
            (2) any procedures for further review of the declining of 
        such supplement; and
            (3) the individual's right to file with the entity a 
        concise statement setting forth the requested supplement and 
        the individual's reasons for disagreeing with the declining 
        entity and the individual's right to include a copy of this 
        refusal in his or her health record.
    (c) Statement of Disagreement.--If an individual has filed a 
statement of disagreement under subsection (b)(3), the entity involved, 
in any subsequent disclosure of the disputed portion of the 
information--
            (1) shall include, at the individual's request, a copy of 
        the individual's statement; and
            (2) may include a concise statement of the reasons for not 
        making the requested supplement.
    (d) Rules Governing Agents.--The agent of an entity described in 
subsection (a) shall not be required to make supplements to protected 
health information, except where--
            (1) the protected health information is retained by the 
        agent; and
            (2) the agent has been asked by such entity to fulfill the 
        requirements of this section.

SEC. 103. NOTICE OF PRIVACY PRACTICES.

    (a) Preparation of Written Notice.--A health care provider, health 
plan, health oversight agency, public health authority, employer, 
health researcher, health or life insurer, school, or university, or 
the agent of any such individual or entity, shall prepare a written 
notice of the privacy practices of the entity that shall include--
            (1) the procedures for an individual to authorize 
        disclosures of protected health information, and to object to, 
        modify, and revoke such authorizations;
            (2) the right of an individual to inspect, copy, and 
        supplement the protected health information;
            (3) the right of an individual not to have employment or 
        the receipt of services conditioned upon the execution by the 
        individual of an authorization for disclosure;
            (4) a description of the categories or types of employees, 
        by general category or by general job description, who have 
        access to or use of protected health information within the 
        entity;
            (5) a simple, concise description of any information 
        systems used to store or transmit protected health information, 
        including a description of any linkages made with other 
        electronic systems or databases outside the entity;
            (6) the right of the individual to request segregation of 
        protected health information, and to restrict the use of such 
        information by employees, agents, and contractors of an entity;
            (7) the circumstances under which the information may be 
        used or disclosed without an authorization executed by the 
        individual; and
            (8) a statement that an individual may self pay for health 
        care in order that no identifying information be disclosed to 
        anyone other than the health care provider unless such 
        disclosure is related to the medical treatment or is authorized 
        by mandatory reporting requirements or other similar 
        information collection duties as required by law.
    (b) Provision and Posting of Written Notice.--
            (1) Provision.--An entity described in subsection (a) shall 
        provide a copy of the written notice of privacy practices 
        required under such subsection--
                    (A) at the time an authorization is sought for 
                disclosure of protected health information; and
                    (B) upon the request of an individual.
            (2) Posting.--An entity described in subsection (a) shall 
        post, in a clear and conspicuous manner, a brief summary of the 
        privacy practices of the entity.
    (c) Model Notice.--The director of the Office of Health Information 
Privacy, after notice and opportunity for public comment, shall develop 
and disseminate model notices of privacy practices, and model summary 
notices for posting, for use under this section.

                Subtitle B--Establishment of Safeguards

SEC. 111. ESTABLISHMENT OF SAFEGUARDS.

    (a) In General.--A health care provider, health plan, health 
oversight agency, public health authority, employer, health researcher, 
law enforcement official, health or life insurer, school, or 
university, or the agent of any such individual or entity, shall 
establish and maintain appropriate administrative, organizational, 
technical, and physical safeguards and procedures to ensure the 
confidentiality, security, accuracy, and integrity of protected health 
information created, received, obtained, maintained, used, transmitted, 
or disposed of by such entity.
    (b) Model Guidelines.--The director of the Office of Health 
Information Privacy, after notice and opportunity for public comment, 
shall develop and disseminate model guidelines for the establishment of 
safeguards for use under this section such as, where appropriate, 
individual authentication of uses of computer systems, access controls, 
audit trials, physical security, protection of remote access points and 
protection of external electronic communications, periodic security 
assessments, incident internal reports in sanctions, and such other 
systems as new technologies and problems develop. The director 
shall update and disseminate such new guidelines, as appropriate to 
take advantage of new technologies.

SEC. 112. ACCOUNTING FOR DISCLOSURES.

    (a) In General.--
            (1) Record of disclosure.--A health care provider, health 
        plan, health oversight agency, public health authority, 
        employer, health researcher, law enforcement official, health 
        or life insurer, school, or university, or the agent of any 
        such individual or entity, shall establish and maintain, with 
        respect to any protected health information disclosure that is 
        not related to payment or treatment, a record of the disclosure 
        in accordance with regulations issued by the director of the 
        Office of Health Information Privacy.
            (2) Agent.--An agent shall maintain a record of disclosures 
        made pursuant to subtitles B and C of title III.
    (b) Maintenance of Record.--A record established under subsection 
(a) shall be maintained for not less than 7 years.
    (c) Electronic Records.--A health care provider, health plan, 
health oversight agency, public health authority, employer, health 
researcher, law enforcement official, health or life insurer, school, 
or university, or the agent of any such individual or entity, shall, to 
the extent practicable, maintain an electronic record, or the ability 
to generate such a record, concerning each attempt that is made by such 
an entity, or by any other person, whether authorized or unauthorized, 
successful or unsuccessful, to access protected health information 
maintained by such entity in electronic form. The record shall include 
the identity of the specific individual attempting to gain such access, 
or a way to identify that individual, and other appropriate 
information, and information sufficient to identify the information 
sought.

              TITLE II--RESTRICTIONS ON USE AND DISCLOSURE

                    Subtitle A--General Restriction

SEC. 201. GENERAL RULE REGARDING USE AND DISCLOSURE.

    A health care provider, health plan, health oversight agency, 
public health authority, employer, health researcher, law enforcement 
official, health or life insurer, school, or university, or the agent 
of any such individual or entity, may not disclose protected health 
information except as authorized under this title.

SEC. 202. AUTHORIZATIONS FOR DISCLOSURE OF PROTECTED HEALTH 
              INFORMATION.

    (a) Written Authorizations.--A health care provider, health plan, 
health oversight agency, public health authority, employer, health 
researcher, health or life insurer, school, or university, or the agent 
of any such individual or entity, may disclose protected health 
information pursuant to an authorization executed by the individual who 
is the subject of the information that meets the requirements of 
subsection (b).
    (b) Requirements for Individual Authorization.--To be valid, an 
authorization to disclose individually identifiable health care 
information shall--
            (1) identify the type of person (by title, general job 
        description, or other functional description) or entity 
        authorized to disclose protected health information;
            (2) describe the nature of the health care information to 
        be disclosed;
            (3) identify the type of person or entity (including 
        identification made with respect to employees through use of a 
        job description, title, or other functional description) to 
        whom the information is to be disclosed, including individuals 
        employed by or operating within the entity;
            (4) describe the purpose of the disclosure;
            (5) permit an individual to indicate that a particular 
        person or entity listed on the authorization is not authorized 
        to receive protected health information concerning the 
        individual, except that a physician directly responsible for 
        providing necessary medical care, and those directly assisting 
        such physician, shall be permitted access to files related to 
        providing that medical care;
            (6) provide the means by which an individual may indicate 
        that some of the individual's protected health information 
        should be segregated;
            (7) permit an individual to indicate that protected health 
        information, other than administrative billing information, 
        shall not be transmitted outside the entity in a computerized, 
        digital, optical, or other electronic format;
            (8) be subject to revocation by the individual and indicate 
        that the authorization is valid until revocation by the 
        individual or until an event or date specified; and
            (9)(A) be either--
                    (i) in writing, dated, and signed by the 
                individual; or
                    (ii) in electronic form, dated and authenticated by 
                the individual using a unique identifier; and
            (B) not have been revoked under paragraph (8).
    (c) Limitation on Authorizations.--
            (1) In general.--Subject to paragraphs (3) and (4), an 
        entity described in subsection (a) that seeks an authorization 
        under such subsection may not condition the delivery of 
        treatment or payment for services on the receipt of an 
        authorization.
            (2) Authorization for payment purposes.--An entity 
        described in subsection (a) that seeks an authorization under 
        such subsection may not condition delivery of health care or 
        payment for services upon receipt of an authorization to link, 
        aggregate, match, index or associate protected health 
        information contained within a computerized, digital, optical 
        or other electronic format with other such information held by 
        another entity.
            (3) Right to require self payment.--If an individual has 
        refused to provide an authorization of disclosure of 
        administrative billing information to a person or entity and 
        such authorization is necessary for a health care provider to 
        receive payment for services delivered, the person or entity 
        seeking the authorization may require the individual to self-
        pay for the services.
            (4) Authorization for treatment purposes.--If a health care 
        provider that is seeking an authorization for disclosure of an 
        individual's protected health information believes that the 
        disclosure of such information is necessary so as not to 
        endanger the health or treatment of the individual, the health 
        care provider may condition the provision of services upon the 
        execution of the authorization by the individual.
    (d) Model Authorizations.--The Secretary, after notice and 
opportunity for public comment, shall develop and disseminate model 
written authorizations of the type described in subsection (a) and 
model statements of the limitations on authorizations. Any 
authorization obtained on a model authorization form developed by the 
Secretary pursuant to the preceding sentence shall be deemed to meet 
the authorization requirements of this section.
    (e) General Rules Applying to Authorizations for Disclosure.--
            (1) Scope of disclosure.--The disclosure of protected 
        health information under an authorization provided under this 
        section shall be limited to the minimum amount of information 
        necessary to accomplish the purpose for which the authorization 
        was executed.
            (2) Use of disclosure for purpose only.--A recipient of 
        information pursuant to an authorization under this section may 
        use or disclose such information solely to carry out the 
        purpose for which the information was authorized for release.
            (3) No general requirement to disclose.--Nothing in this 
        section permitting the disclosure of protected health 
        information shall be construed to require such disclosure.
            (4) Identification of disclosed information as protected 
        health information.--Protected health information disclosed 
        pursuant to an authorization under this section shall be 
        clearly identified as protected health information that is 
        subject to this Act.
    (f) Segregation of Files.--An entity described in subsection (a) 
shall comply with the request of an individual who is the subject of 
protected health information to--
            (1) segregate any type or amount of protected health 
        information, other than administrative billing information, 
        held by the entity;
            (2) limit the use or disclosure of the segregated health 
        information within the entity to those persons specifically 
        designated by the subject of the protected health information; 
        and
            (3) maintain such information outside any networked 
        computerized, digital, optical or other electronic system.
    (g) Revocation of Authorization.--
            (1) In general.--An individual may in writing revoke or 
        amend an authorization under this section at any time, unless 
        the disclosure that is the subject of the authorization is 
        required to effectuate payment for health care that has been 
        provided to the individual.
            (2) Health plans.--With respect to a health plan, the 
        authorization of an individual is deemed to be revoked at the 
        time of the cancellation or non-renewal of enrollment in the 
        health plan, except as may be necessary to complete plan 
        administration and payment requirements related to the 
        individual's period of enrollment.
            (3) Actions.--An individual may not maintain an action 
        against a person for disclosure of personally identifiable 
        health information--
                    (A) if the disclosure was made based on a good 
                faith reliance on the individual's authorization at the 
                time disclosure was made;
                    (B) in a case in which the authorization is 
                revoked, if the disclosing entity had no actual or 
                constructive notice of the revocation; or
                    (C) if the disclosure was for the purpose of 
                protecting another individual from imminent physical 
                harm, if authorized under section 211.
    (h) Record of Individual's Authorizations and Revocations.--Each 
person collecting or storing personally identifiable health information 
shall maintain a record for a period of 7 years of each authorization 
of an individual and any revocation thereof, and such record shall 
become part of the personally identifiable health information 
concerning such individual.
    (i) No Waiver.-- Except as provided for in this Act, an 
authorization to disclose personally identifiable health information by 
an individual shall not be construed as a waiver of any rights that the 
individual has under other Federal or State laws, the rules of 
evidence, or common law.
    (j) Rule of Construction.--Except as provided in subsection (a), 
nothing in this section shall be construed to prevent the electronic or 
computerized exchange of administrative billing information for the 
purpose of a claims payment.
    (k) Definition.--For purposes of this section--
            (1) the term ``segregate'' means to place a designated 
        subset of protected health information in a location or 
        computer file that is separate from the location or computer 
        file used to store general protected health information and 
        where access to or use of any information so segregated may be 
        effectively limited to those individuals who are authorized to 
        access or use such information; and
            (2) the terms ``signed'' refers to both signatures in ink 
        and electronic signatures, and ``written'' refers to both paper 
        and computerized formats.

  Subtitle B--Limited Circumstances Providing for Disclosure Without 
                             Authorization

SEC. 211. EMERGENCY CIRCUMSTANCES.

    (a) General Rule.--In the event of a threat of imminent physical or 
mental harm to the subject of protected health information, any person 
may, in order to allay or remedy such threat, disclose protected health 
information about such subject to a health care practitioner, health 
care facility, law enforcement authority, or emergency medical 
personnel to protect the health or safety of such subject.
    (b) Harm to Others.--In the event of a threat of harm to an 
individual other than the subject of protected health information, any 
person may disclose protected health information about such subject 
where--
            (1) there is an identifiable threat of serious injury or 
        death to an identifiable individual or group of individuals;
            (2) the subject of the protected health information has the 
        ability to carry out such threat; and
            (3) the release of such information is necessary to prevent 
        or significantly reduce the possibility of such threat.
    (c) Limitations.--
            (1) Scope of disclosure.--Every disclosure of protected 
        health information under this section shall be limited to the 
        minimum amount of information necessary to achieve the purposes 
        of this section.
            (2) Use or disclosure for purpose only.--A recipient of 
        information pursuant to this section may use or disclose such 
        information solely to carry out the purposes of this section.
            (3) Identification of disclosed information as protected 
        health information.--Protected health information disclosed 
        under this section must be clearly identified as protected 
        health information that is subject to this Act.

SEC. 212. PUBLIC HEALTH.

    (a) General Rule.--A health care provider, health plan, public 
health authority, health researcher, employer, law enforcement 
official, health or life insurer, school or university, or the agent of 
any such individual or entity, may disclose protected health 
information concerning an individual to a public health authority 
where--
            (1) there is a specific nexus between the individual's 
        identity and a threat of a specific disease, death, or injury 
        to any individual or to the public health; and
            (2) the individual's identity would allow such public 
        health authority to prevent or significantly reduce the 
        possibility of injury or death to any individual or the public 
        health, such as the creation and use of disease registries 
        established under Federal or State law.
    (b) Exception.--An entity described in subsection (a) shall not be 
liable for the disclosure of protected health information--
            (1) to a public health authority based upon a good faith 
        belief and credible representation made by such authority that 
        such information was required to protect an individual or the 
        public health from a threat of a specific disease, injury, or 
        death; or
            (2) if such disclosure is made pursuant to Federal or state 
        laws which are designed to protect the public health or safety.

SEC. 213. PROTECTION AND ADVOCACY AGENCIES.

    (a) General Rule.--Any person who creates or receives protected 
health information under this title may disclose protected health 
information to an agency charged by law to protect the health and 
safety of individuals when such agency can establish that there is 
probable cause to believe that an individual who is the subject of the 
protected health information is vulnerable to abuse or neglect by an 
entity providing health or social services to such individual.
    (b) Limitations.--
            (1) Scope of disclosure.--Every disclosure of protected 
        health information under this section shall be limited to the 
        minimum amount of information necessary to achieve the purposes 
        of this section.
            (2) Use or disclosure for purpose only.--A recipient of 
        information pursuant to this section may use or disclose such 
        information solely to achieve the purposes of this section.
            (3) Identification of disclosed information as protected 
        health information.--Protected health information disclosed 
        under this section must be clearly identified as protected 
        health information that is subject to this Act.

SEC. 214. OVERSIGHT.

    (a) General Rule.--A health care provider, health plan, public 
health authority, health researcher, employer, law enforcement 
official, health or life insurer, school or university, or the agent of 
any such individual or entity, may disclose protected health 
information concerning an individual to a health oversight agency to 
enable the agency to perform a health oversight function authorized by 
law only if the agency--
            (1) does not record the name, social security number, or 
        other identifying information of the individual from patient or 
        client files;
            (2) identifies the individual in all workpapers and 
        electronic records by either relying upon a unit record number 
        contained in the file or by using another formula to scramble 
        or otherwise safeguard the identifying information; and
            (3) does not remove protected health information from the 
        premises, custody or control of such entity.
    (b) Nonidentifiable Information.--An entity described in subsection 
(a) may disclose health information concerning an individual to a 
health oversight agency to perform a health oversight function 
authorized by law when any information that could reasonably be 
expected to identify the individual has been removed or concealed.
    (c) Prohibition in Use in Action Against Individuals.--Protected 
health information about an individual that is disclosed under this 
section may not be used in, or disclosed to any person for use in, an 
administrative, civil, or criminal action or investigation directed 
against the individual.
    (d) Authorization by a Supervisor.--For purposes of this section, 
the individual with authority to authorize the oversight function 
involved shall provide to the entity described in subsections (a) or 
(b) a statement that the protected health information is being sought 
for a legally authorized oversight function.
    (e) Limitations.--
            (1) Scope of disclosure.--Every disclosure of protected 
        health information under this section shall be limited to the 
        minimum amount of information necessary to achieve the purposes 
        of this section.
            (2) Use of disclosure for purpose only.--A recipient of 
        information pursuant to this section may use or disclose such 
        information solely to achieve the purposes of this section.
            (3) No general requirement to disclose.--Nothing in this 
        section permitting the disclosure of protected health 
        information shall be construed to require such disclosure.
            (4) Identification of disclosed information as protected 
        health information.--Protected health information disclosed 
        under this section must be clearly identified as protected 
        health information that is subject to this Act.

SEC. 215. DISCLOSURE FOR LAW ENFORCEMENT PURPOSES.

    (a) Law Enforcement Access to Protected Health Information.--A 
health care provider, health researcher, health plan, health oversight 
agency, employer, health or life insurer, school, university, or the 
agent of any such individual or entity, or person who receives 
protected health information pursuant to section 211, may disclose 
protected health information to a law enforcement authority only if the 
disclosure is made pursuant to a court order issued by a court of 
competent jurisdiction in accordance with subsections (b) and (c) or 
otherwise ordered by a Court of competent jurisdiction.
    (b) Court Orders for Access to Protected Health Information.--A 
court order for the disclosure of protected health information under 
subsection (a) may be issued only if the law enforcement authority 
involved submits a written application upon oath or affirmation and 
demonstrates by clear and convincing evidence that--
            (1) the protected health information sought is necessary to 
        a legitimate law enforcement inquiry into a particular 
        violation of criminal law being conducted by the authority;
            (2) the investigative or evidentiary needs of the law 
        enforcement authority cannot be satisfied by nonidentifiable 
        health information or by any other information; and
            (3) the law enforcement need for the information outweighs 
        the privacy interest of the individual to whom the information 
        pertains.
    (c) Notice.--
            (1) In general.--Except as provided in paragraph (2), no 
        order for the disclosure of protected health information about 
        an individual may be issued by a court under this section 
        unless notice of the application for the order has been served 
        on the individual who is the subject of the information 
        involved and the individual has been afforded an opportunity to 
        oppose the issuance of the order.
            (2) Notice not required.--An order for the disclosure of 
        protected health information about an individual may be issued 
        without notice to the individual if the court finds, by clear 
        and convincing evidence, that notice would be impractical 
        because--
                    (A) the name and address of the individual are 
                unknown; or
                    (B) notice would risk destruction or unavailability 
                of the evidence.
    (d) Conditions.--Upon the granting of an order for disclosure of 
protected health information under this section, the court shall impose 
appropriate safeguards to ensure the confidentiality of such 
information and to protect against unauthorized or improper use or 
disclosure.
    (e) Limitation on Use and Disclosure for Other Law Enforcement 
Inquiries.--Protected health information about an individual that is 
disclosed under this section may not be used in, or disclosed to any 
person for use in, any administrative, civil, or criminal action or 
investigation directed against the individual, unless the action or 
investigation arises out of, or is directly related to, the law 
enforcement inquiry for which the information was obtained.
    (f) Destruction or Return of Information.--When the matter or need 
for which protected health information was disclosed to a law 
enforcement agency or grand jury has concluded, including any 
derivative matters arising from such matter or need, the law 
enforcement agency or grand jury shall either destroy the protected 
health information, or return it to the person from whom it was 
obtained.
    (g) Redactions.--To the extent practicable, and consistent with the 
requirements of due process, a law enforcement agency shall redact 
personally identifying information from protected health information 
prior to the public disclosure of such protected information in a 
judicial or administrative proceeding.
    (h) Limitations.--
            (1) Scope of disclosure.--Every disclosure of protected 
        health information under this section shall be limited to the 
        minimum amount of information necessary to fulfill the purposes 
        of this section.
            (2) Use or disclosure for purpose only.--A recipient of 
        information pursuant to this section may use or disclose such 
        information solely to fulfill the purposes of this section.
            (3) Identification of disclosed information as protected 
        health information.--Protected health information disclosed 
        under this section must be clearly identified as protected 
        health information that is subject to this Act.
    (i) Exception.--This section shall not be construed to limit or 
restrict the ability of law enforcement authorities to gain information 
while in hot pursuit of a suspect or if other exigent circumstances 
exist.

             Subtitle C--Special Rules Governing Disclosure

SEC. 221. NEXT OF KIN AND DIRECTORY INFORMATION.

    (a) Next of Kin.--A health care provider, or a person who receives 
protected health information under section 211, may not disclose 
protected health information regarding an individual to the 
individual's next of kin, or to another person whom the individual has 
identified, unless at the time of the treatment of the individual--
            (1) the individual who is the subject of the information--
                    (A) has been notified of the individual's right to 
                object to such disclosure and the individual has not 
                objected to the disclosure; or
                    (B) is in a physical or mental condition such that 
                the individual is not capable of objecting, and there 
                are no prior indications that the individual would 
                object; and
            (2) the information disclosed relates to health care 
        currently being provided to that individual.
    (b) Directory Information.--
            (1) Disclosure.--
                    (A) In general.--Except as provided in paragraph 
                (2), an entity described in subsection (a) may not 
                disclose the information described in subparagraph (B) 
                to any person unless, at the time of the admission of 
                the individual who is the subject of the information to 
                a facility, the individual--
                            (i) has been notified of the individual's 
                        right to object and the individual has not 
                        objected to the disclosure; or
                            (ii) is in a physical or mental condition 
                        such that the individual is not capable of 
                        objecting and there are no prior indications 
                        that the individual would object.
                    (B) Information.--Information described in this 
                subparagraph is information that consists only of 1 or 
                more of the following items:
                            (i) The name of the individual who is the 
                        subject of the information.
                            (ii) The general health status of the 
                        individual, described as critical, poor, fair, 
                        stable, or satisfactory or in terms denoting 
                        similar conditions.
                            (iii) The location of the individual on 
                        premises controlled by a provider.
            (2) Exception.--
                    (A) Location.--Paragraph (1)(B)(iii) shall not 
                apply if disclosure of the location of the individual 
                would reveal specific information about the physical or 
                mental condition of the individual, unless the 
                individual expressly authorizes such disclosure.
                    (B) Directory or next of kin information.--A 
                disclosure may not be made under this section if the 
                health care provider involved has reason to believe 
                that the disclosure of directory or next of kin 
                information could lead to the physical or mental harm 
                of the individual, unless the individual expressly 
                authorizes such disclosure.
    (c) Identification of Deceased Individual.--An entity described in 
subsection (a) may disclose protected health information if such 
disclosure is necessary to assist in the identification of a deceased 
individual.
    (d) Rights of Minors.--
            (1) Individuals who are 18 or legally capable.--In the case 
        of an individual--
                    (A) who is 18 years of age or older, all rights of 
                the individual shall be exercised by the individual; or
                    (B) who, acting alone, can obtain a type of health 
                care without violating any applicable law, and who has 
                sought such care, the individual shall exercise all 
                rights of an individual under this title with respect 
                to protected health information relating to such health 
                care.
            (2) Individuals under 18.--Except as provided in 
        subparagraph (1)(B) of this subsection, in the case of an 
        individual who is--
                    (A) under 14 years of age, all of the individual's 
                rights under this title shall be exercised through the 
                parent or legal guardian; or
                    (B) 14 through 17 years of age, the rights of 
                inspection and supplementation, and the right to 
                authorize use and disclosure of protected health 
                information of the individual shall be exercised by the 
                individual, or by the parent or legal guardian of the 
                individual.
    (e) General Rules Applying to Disclosures of Protected Health 
Information With Respect to Next of Kin and Directory Information.--
            (1) Scope of disclosure.--Every disclosure of protected 
        health information under this section shall be limited to the 
        minimum amount of information necessary to achieve the purposes 
        of this section.
            (2) No general requirement to disclose.--Nothing in this 
        section permitting the disclosure of protected health 
        information shall be construed to require such disclosure.

SEC. 222. HEALTH RESEARCH.

    (a) In General.--The requirements and protections provided for 
under part 46 of title 45, Code of Federal Regulations (as in effect on 
the date of enactment of this Act), shall apply to research conducted 
by all research facilities using personally identifiable health 
information. The Secretary shall promulgate regulations to implement 
this subsection through notice and comment rulemaking.
    (b) Evaluation.--Not later than 1 year after the date of enactment 
of this Act, the Secretary shall prepare and submit to Congress 
detailed recommendations on whether written informed consent should be 
required, and if so, under what circumstances, before personally 
identifiable data can be used for medical research.
    (c) Recommendations.--The recommendations required to be submitted 
under subsection (b) shall include--
            (1) a detailed explanation of current institutional review 
        board practices, including under what circumstances informed 
        consent is being waived and the extent to which the privacy of 
        individuals is taken into account as a factor before allowing 
        waivers;
            (2) a summary of how technology could be used to strip 
        identifying data for the purposes of research;
            (3) an analysis of the risks and benefits of requiring 
        informed consent versus the waiving informed consent; and
            (4) an analysis of the risks and benefits of using 
        protected health information for research purposes other than 
        the health research project for which such information was 
        obtained.
    (d) Compliance With Deadline.--Notwithstanding any other provision 
of law, if the Secretary does not submit the recommendations to 
Congress by the date described in subsection (b), the authority of the 
Secretary to permit the conduct of medical research using personally 
identifiable data without written informed consent shall be terminated.
    (e) Consultation.--In carrying out this section, the Secretary 
shall consult with individuals who have distinguished themselves in the 
fields of health research, privacy, related technology, consumer 
interests in health information, health data standards, and the 
provision of health services.
    (f) Congressional Notice.--Not later than 6 months after the date 
on which the Secretary submits to Congress the recommendations required 
under subsection (b), the Secretary shall propose to implement such 
recommendations through notice and comment rulemaking and shall advise 
Congress of such proposal.
    (g) Termination of Inconsistent Authority.--Notwithstanding any 
other provision of law, if the Secretary determines that prior written 
informed consent is appropriate for some or all research using 
personally identifiable health information, the authority of the 
Secretary to promulgate regulations inconsistent with that 
determination shall be terminated 6 months after the date on which such 
determination is made pursuant to this Act.
    (h) Other Requirements.--
            (1) Obligations of the recipient.--A person who receives 
        protected health information pursuant to this section--
                    (A) shall remove or destroy, at the earliest 
                opportunity consistent with the purposes of the project 
                involved, information that would enable an individual 
                to be identified, unless--
                            (i) an institutional review board has 
                        determined that there is a health or research 
                        justification for the retention of such 
                        identifiers; and
                            (ii) there is an adequate plan to protect 
                        the identifiers from disclosure consistent with 
                        this section; and
            (2) Periodic review and technical assistance.--
                    (A) Institutional review board.--Any institutional 
                review board that authorizes research under this 
                section shall provide the Secretary with the names and 
                addresses of the institutional review board members.
                    (B) Technical assistance.--The Secretary may 
                provide technical assistance to institutional review 
                boards described in this subsection.
                    (C) Monitoring.--The Secretary shall periodically 
                monitor institutional review boards described in this 
                subsection.
                    (D) Reports.--Not later than 3 years after the date 
                of enactment of this Act, the Secretary shall report to 
                Congress regarding the activities of institutional 
                review boards described in this subsection.
    (i) Limitation.--Nothing in this section shall be construed to 
permit personally identifiable health information that is received by a 
researcher under this section to be accessed for purposes other than 
research or as authorized by the individual.

SEC. 223. JUDICIAL AND ADMINISTRATIVE PURPOSES.

    (a) In General.--A health care provider, health plan, health 
oversight agency, employer, insurer, health or life insurer, school or 
university, or the agent of any such individual or entity, or person 
who receives protected health information under section 211, may 
disclose protected health information--
            (1) pursuant to the standards and procedures established in 
        the Federal Rules of Civil Procedure, the Federal Rules of 
        Criminal Procedure, or comparable rules of other courts or 
        administrative agencies, in connection with litigation or 
        proceedings to which the individual who is the subject of the 
        information is a party and in which the individual has placed 
        his or her physical or mental condition at issue;
            (2) to a court, and to others ordered by the court, if in 
        response to a court order issued by a court of competent 
        jurisdiction in accordance with subsections (b) and (c); or
            (3) if necessary to present to a court an application 
        regarding the provision of treatment of an individual or the 
        appointment of a guardian pursuant to a law requiring the 
        reporting of specific medical information to law enforcement 
        authorities.
    (b) Court Orders for Access to Protected Health Information.--A 
court order for the disclosure of protected health information under 
subsection (a) may be issued only if the person seeking disclosure 
submits a written application upon oath or affirmation and demonstrates 
by clear and convincing evidence that--
            (1) the protected health information sought is necessary 
        for the adjudication of a material fact in dispute in a civil 
        or criminal proceeding;
            (2) the adjudicative need cannot be satisfied by 
        nonidentifiable health information or by any other information; 
        and
            (3) the need for the information outweighs the privacy 
        interest of the individual to whom the information pertains.
    (c) Notice.--
            (1) In general.--Except as provided in paragraph (2), no 
        order for the disclosure of protected health information about 
        an individual may be issued by a court unless notice of the 
        application for the order has been served on the individual and 
        the individual has been afforded an opportunity to oppose the 
        issuance of the order.
            (2) Notice not required.--An order for the disclosure of 
        protected health information about an individual may be issued 
        without notice to the individual if the court finds, by clear 
        and convincing evidence, that notice would be impractical 
        because--
                    (A) the name and address of the individual are 
                unknown; or
                    (B) notice would risk destruction or unavailability 
                of the evidence.
    (d) Obligations of Recipient.--
            (1) In general.--A person seeking protected health 
        information pursuant to paragraph (1) of subsection (a)--
                    (A) shall notify the individual or the individual's 
                attorney of the request for the information;
                    (B) shall provide the health care provider, health 
                plan, health oversight agency, employer, insurer, 
                health or life insurer, school or university, or agent, 
                or person involved with a signed document attesting--
                            (i) that the individual has placed his or 
                        her physical or mental condition at issue in 
                        litigation or proceedings in which the 
                        individual is a party; and
                            (ii) the date on which the individual or 
                        the individual's attorney was notified under 
                        subparagraph (A); and
                    (C) shall not accept any requested protected health 
                information from the health care provider, health plan, 
                health oversight agency, employer, insurer, health or 
                life insurer, school or university, or agent, or person 
                until the termination of the 10-day period beginning on 
                the date notice was given under subparagraph (A).
            (2) Disclosure for purpose only.--A person who receives 
        protected health information pursuant to subsection (a) may 
        disclose the information only to accomplish the purpose for 
        which the protected health information was obtained.
    (e) Limitations.--
            (1) Scope of disclosure.--Every disclosure of protected 
        health information under this section shall be limited to the 
        minimum amount of information necessary to achieve the purposes 
        of this section.
            (2) No general requirement to disclose.--Nothing in this 
        section permitting the disclosure of protected health 
        information shall be construed to require such disclosure.
            (3) Identification of disclosed information as protected 
        health information.--Protected health information disclosed 
        under this section must be clearly identified as protected 
        health information that is subject to this Act.

SEC. 224. INDIVIDUAL REPRESENTATIVES.

    (a) In General.--Except as provided in subsections (b) and (c), a 
person who is authorized by law (based on grounds other than the 
individual being a minor), or by an instrument recognized under law, to 
act as an agent, attorney, proxy, or other legal representative of a 
protected individual, may, to the extent so authorized, exercise and 
discharge the rights of the individual under this Act.
    (b) Health Care Power of Attorney.--A person who is authorized by 
law (based on grounds other than being a minor), or by an instrument 
recognized under law, to make decisions about the provision of health 
care to an individual who is incapacitated, may exercise and discharge 
the rights of the individual under this Act to the extent necessary to 
effectuate the terms or purposes of the grant of authority.
    (c) No Court Declaration.--If a physician or other health care 
provider determines that an individual, who has not been declared to be 
legally incompetent, suffers from a medical condition that prevents the 
individual from acting knowingly or effectively on the individual's own 
behalf, the right of the individual to authorize disclosure under this 
Act may be exercised and discharged in the best interest of the 
individual by--
            (1) a person described in subsection (b) with respect to 
        the individual;
            (2) a person described in subsection (a) with respect to 
        the individual, but only if a person described in paragraph (1) 
        cannot be contacted after a reasonable effort;
            (3) the next of kin of the individual, but only if a person 
        described in paragraph (1) or (2) cannot be contacted after a 
        reasonable effort; or
            (4) the health care provider, but only if a person 
        described in paragraph (1), (2), or (3) cannot be contacted 
        after a reasonable effort.
    (d) Application to Deceased Individuals.--The provisions of this 
Act shall continue to apply to protected health information concerning 
a deceased individual for a period of 2 years following the death of 
that individual.
    (e) Exercise of Rights on Behalf of a Deceased Individual.--A 
person who is authorized by law or by an instrument recognized under 
law, to act as an executor of the estate of a deceased individual, or 
otherwise to exercise the rights of the deceased individual, may, to 
the extent so authorized, exercise and discharge the rights of such 
deceased individual under this Act for a period of 2 years following 
the death of that individual. If no such designee has been authorized, 
the rights of the deceased individual may be exercised as provided for 
in subsection (c).

SEC. 325. PROHIBITION AGAINST RETALIATION.

    A health care provider, health researcher, health plan, health 
oversight agency, employer, health or life insurer, school or 
university, or the agent of any such individual or entity, or person 
who receives protected health information under section 211 may not 
adversely affect another person, directly or indirectly, because such 
person has exercised a right under this Act, disclosed information 
relating to a possible violation of this Act, or associated with, or 
assisted a person in the exercise of a right under this Act.

 TITLE III--OFFICE OF HEALTH INFORMATION PRIVACY OF THE DEPARTMENT OF 
                       HEALTH AND HUMAN SERVICES

                       Subtitle A--Establishment

SEC. 301. ESTABLISHMENT.

    (a) In General.--There is established within the Department of 
Health and Human Services an office to be known as the Office of Health 
Information Privacy. The Office shall be headed by a director, who 
shall be appointed by the Secretary.
    (b) Duties.--The Director of the Office of Health Information 
Privacy shall--
            (1) receive and investigate complaints of alleged 
        violations of this Act;
            (2) provide for the conduct of audits where appropriate;
            (3) provide guidance to the Secretary in the implementation 
        of this Act;
            (4) prepare and submit the report described in subsection 
        (c);
            (5) consult with, and provide recommendation to, the 
        Secretary concerning improvements in the privacy and security 
        of protected health information and concerning medical privacy 
        research needs; and
            (6) carry out any other activities determined appropriate 
        by the Secretary.
    (c) Report on Compliance.--Not later than January 1, 1999, and 
every January 1 thereafter, the Director of the Office of Health 
Information Privacy shall prepare and submit to Congress a report 
concerning the number of complaints of alleged violations of this Act 
that are received during the year for which the report is being 
prepared. Such report shall describe the complaints and any remedial 
action taken concerning such complaints.

                        Subtitle B--Enforcement

                     CHAPTER 1--CRIMINAL PROVISIONS

SEC. 311. WRONGFUL DISCLOSURE OF PROTECTED HEALTH INFORMATION.

    (a) In General.--Part I of title 18, United States Code, is amended 
by adding at the end the following:

   ``CHAPTER 124--WRONGFUL DISCLOSURE OF PROTECTED HEALTH INFORMATION

        ``Sec.
        ``2801. Wrongful disclosure of protected health information.
``Sec. 2801. Wrongful disclosure of protected health information
    ``(a) Offense.--The penalties described in subsection (b) shall 
apply to a person that knowingly and intentionally--
            ``(1) obtains protected health information relating to an 
        individual in violation of title II of the Medical Information 
        Privacy and Security Act; or
            ``(2) discloses protected health information to another 
        person in violation of title II of the Medical Information 
        Privacy and Security Act.
    ``(b) Penalties.--A person described in subsection (a) shall--
            ``(1) be fined not more than $50,000, imprisoned not more 
        than 1 year, or both;
            ``(2) if the offense is committed under false pretenses, be 
        fined not more than $250,000, imprisoned not more than 5 years, 
        or any combination of such penalties;
            ``(3) if the offense is committed with the intent to sell, 
        transfer, or use protected health information for commercial 
        advantage, personal gain, or malicious harm, be fined not more 
        than $500,000, imprisoned not more than 10 years, excluded from 
        participation in any Federally funded health care programs, or 
        any combination of such penalties.
    ``(c) Subsequent Offenses.--In the case of a person described in 
subsection (a), the maximum penalties described in subsection (b) shall 
be doubled for every subsequent conviction for an offense arising out 
of a violation or violations related to a set of circumstances that are 
different from those involved in the previous violation or set of 
related violations described in such subsection (a).''.
    (b) Clerical Amendment.--The table of chapters for part I of title 
18, United States Code, is amended by inserting after the item relating 
to chapter 123 the following new item:

``124. Wrongful disclosure of protected health information..    2801''.

SEC. 312. DEBARMENT FOR CRIMES.

    (a) Purpose.--The purpose of this section is to promote the 
prevention and deterrence of instances of intentional criminal actions 
which violate criminal laws which are designed to protect the privacy 
of protected health information in a manner consistent with this Act.
    (b) Debarment.--Not later than 270 days after the date of enactment 
of this Act, the Attorney General, in consultation with the Secretary, 
shall promulgate regulations and establish procedures to permit the 
debarment of health care providers, health researchers, health or life 
insurers, or schools or universities from receiving benefits under any 
Federal health programs if the managers or officers of such entities 
are found guilty of violating section 2801 of title 18, United States 
Code, have civil penalties imposed against such officers or managers 
under section 321 in connection with the illegal disclosure of 
protected health information, or are found guilty of making a false 
statement or obstructing justice related to attempting to conceal or 
concealing such illegal disclosure. Such regulations shall take into 
account the need for continuity of medical care and may provide for a 
delay of any debarment imposed under this section to take into account 
the medical needs of patients.
    (c) Consultation.--Before publishing a proposed rule to implement 
subsection (b), the Attorney General shall consult with State law 
enforcement officials, health care providers, patient privacy rights' 
advocates, and other appropriate individuals and entities, to gain 
additional information regarding the debarment of entities under 
subsection (b) and the best methods to ensure the continuity of medical 
care.
    (d) Report.--The Attorney General shall annually prepare and submit 
to the Committee on the Judiciary of the House of Representatives and 
the Committee on the Judiciary of the Senate a report concerning the 
activities and debarment actions taken by the Attorney General under 
this section.
    (e) Assistance to Prevent Criminal Violations.--The Attorney 
General, in cooperation with any other appropriate individual, 
organization, or agency, may provide advice, training, technical 
assistance, and guidance regarding ways to reduce the incidence of 
improper disclosure of protected health information.
    (f) Relationship to Other Authorities.--A debarment imposed under 
this section shall not reduce or diminish the authority of a Federal, 
State, or local governmental agency or court to penalize, imprison, 
fine, suspend, debar, or take other adverse action against a person, in 
a civil, criminal, or administrative proceeding.

                       CHAPTER 2--CIVIL SANCTIONS

SEC. 321. CIVIL PENALTY.

    (a) Violation.--A health care provider, health researcher, health 
plan, health oversight agency, public health agency, law enforcement 
agency, employer, health or life insurer, school, or university, or the 
agent of any such individual or entity, who the Office of Health 
Information Privacy, in consultation with the Attorney General, 
determines has substantially and materially failed to comply with this 
Act shall be subject, in addition to any other penalties that may be 
prescribed by law--
            (1) in a case in which the violation relates to title I, to 
        a civil penalty of not more than $500 for each such violation, 
        but not to exceed $5000 in the aggregate for multiple 
        violations;
            (2) in a case in which the violation relates to title II, 
        to a civil penalty of not more than $10,000 for each such 
        violation, but not to exceed $50,000 in the aggregate for 
        multiple violations; or
            (3) in a case in which the Office finds that such 
        violations have occurred with such frequency as to constitute a 
        general business practice, to a civil penalty of not more than 
        $100,000.
    (b) Procedures for Imposition of Penalties.--Section 1128A of the 
Social Security Act, other than subsections (a) and (b) and the second 
sentence of subsection (f) of that section, shall apply to the 
imposition of a civil, monetary, or exclusionary penalty under this 
section in the same manner as such provisions apply with respect to the 
imposition of a penalty under section 1128A of such Act.

SEC. 322. PROCEDURES FOR IMPOSITION OF PENALTIES.

    (a) Initiation of Proceedings.--
            (1) In general.--The director of the Office of Health 
        Information Privacy, in consultation with the Attorney General, 
        may initiate a proceeding to determine whether to impose a 
        civil money penalty under section 321. The director may not 
        initiate an action under this section with respect to any 
        violation described in section 321 after the expiration of the 
        6-year period beginning on the date on which such violation was 
        alleged to have occurred. The director may initiate an action 
        under this section by serving notice of the action in any 
        manner authorized by Rule 4 of the Federal Rules of Civil 
        Procedure.
            (2) Notice and opportunity for hearing.--The director of 
        the Office of Health Information Privacy shall not make a 
        determination adverse to any person under paragraph (1) until 
        the person has been given written notice and an opportunity for 
        the determination to be made on the record after a hearing at 
        which the person is entitled to be represented by counsel, to 
        present witnesses, and to cross-examine witnesses against the 
        person.
            (3) Estoppel.--In a proceeding under paragraph (1) that--
                    (A) is against a person who has been convicted 
                (whether upon a verdict after trial or upon a plea of 
                guilty or nolo contendere) of a crime under section 
                2801 of title 18, United States Code; and
                    (B) involves the same conduct as in the criminal 
                action;
        the person is estopped from denying the essential elements of 
        the criminal offense.
            (4) Sanctions for failure to comply.--The official 
        conducting a hearing under this section may sanction a person, 
        including any party or attorney, for failing to comply with an 
        order or procedure, failing to defend an action, or other 
        misconduct as would interfere with the speedy, orderly, or fair 
        conduct of the hearing. Such sanction shall reasonably relate 
        to the severity and nature of the failure or misconduct. Such 
        sanction may include--
                    (A) in the case of refusal to provide or permit 
                discovery, drawing negative factual inferences or 
                treating such refusal as an admission by deeming the 
                matter, or certain facts, to be established;
                    (B) prohibiting a party from introducing certain 
                evidence or otherwise supporting a particular claim or 
                defense;
                    (C) striking pleadings, in whole or in part;
                    (D) staying the proceedings;
                    (E) dismissal of the action;
                    (F) entering a default judgment;
                    (G) ordering the party or attorney to pay 
                attorneys' fees and other costs caused by the failure 
                or misconduct; and
                    (H) refusing to consider any motion or other action 
                which is not filed in a timely manner.
    (b) Scope of Penalty.--In determining the amount or scope of any 
penalty imposed pursuant to section 321, the director of the Office of 
Health Information Privacy shall take into account--
            (1) the nature of claims and the circumstances under which 
        they were presented;
            (2) the degree of culpability, history of prior offenses, 
        and financial condition of the person presenting the claims; 
        and
            (3) such other matters as justice may require.
    (c) Review of Determination.--
            (1) In general.--Any person adversely affected by a 
        determination of the director of the Office of Health 
        Information Privacy under this section may obtain a review of 
        such determination in the United States Court of Appeals for 
        the circuit in which the person resides, or in which the claim 
        was presented, by filing in such court (within 60 days 
        following the date the person is notified of the determination 
        of the director) a written petition requesting that the 
        determination be modified or set aside.
            (2) Filing of record.--A copy of the petition filed under 
        paragraph (1) shall be forthwith transmitted by the clerk of 
        the court to the director of the Office of Health Information 
        Privacy, and thereupon the director shall file in the Court the 
        record in the proceeding as provided in section 2112 of title 
        28, United States Code. Upon such filing, the court shall have 
        jurisdiction of the proceeding and of the question determined 
        therein, and shall have the power to make and enter upon the 
        pleadings, testimony, and proceedings set forth in such record 
        a decree affirming, modifying, remanding for further 
        consideration, or setting aside, in whole or in part, the 
        determination of the director and enforcing the same to the 
        extent that such order is affirmed or modified.
            (3) Consideration of objections.--No objection that has not 
        been raised before the director of the Office of Health 
        Information Privacy with respect to a determination described 
        in paragraph (1) shall be considered by the court, unless the 
        failure or neglect to raise such objection shall be excused 
        because of extraordinary circumstances.
            (4) Findings.--The findings of the director of the Office 
        of Health Information Privacy with respect to questions of fact 
        in an action under this subsection, if supported by substantial 
        evidence on the record considered as a whole, shall be 
        conclusive. If any party shall apply to the court for leave to 
        adduce additional evidence and shall show to the satisfaction 
        of the court that such additional evidence is material and that 
        there were reasonable grounds for the failure to adduce such 
        evidence in the hearing before the director, the court may 
        order such additional evidence to be taken before the director 
        and to be made a part of the record. The director may modify 
        findings as to the facts, or make new findings, by reason of 
        additional evidence so taken and filed, and shall file with the 
        court such modified or new findings, and such findings with 
        respect to questions of fact, if supported by substantial 
        evidence on the record considered as a whole, and the 
        recommendations of the director, if any, for the modification 
        or setting aside of the original order, shall be conclusive.
            (5) Exclusive jurisdiction.--Upon the filing of the record 
        with the court under paragraph (2), the jurisdiction of the 
        court shall be exclusive and its judgment and decree shall be 
        final, except that the same shall be subject to review by the 
        Supreme Court of the United States, as provided for in section 
        1254 of title 28, United States Code.
    (d) Recovery of Penalties.--
            (1) In general.--Civil money penalties imposed under this 
        chapter may be compromised by the director of the Office of 
        Health Information Privacy and may be recovered in a civil 
        action in the name of the United States brought in United 
        States district court for the district where the claim was 
        presented, or where the claimant resides, as determined by the 
        director. Amounts recovered under this section shall be paid to 
        the director and deposited as miscellaneous receipts of the 
        Treasury of the United States.
            (2) Deduction from amounts owing.--The amount of any 
        penalty, when finally determined under this section, or the 
        amount agreed upon in compromise under paragraph (1), may be 
        deducted from any sum then or later owing by the United States 
        or a State to the person against whom the penalty has been 
        assessed.
    (e) Determination Final.--A determination by the director of the 
Office of Health Information Privacy to impose a penalty under section 
321 shall be final upon the expiration of the 60-day period referred to 
in subsection (c)(1). Matters that were raised or that could have been 
raised in a hearing before the director or in an appeal pursuant to 
subsection (c) may not be raised as a defense to a civil action by the 
United States to collect a penalty under section 321.
    (f) Subpoena Authority.--
            (1) In general.--For the purpose of any hearing, 
        investigation, or other proceeding authorized or directed under 
        this section, or relative to any other matter within the 
jurisdiction of the Attorney General hereunder, the Attorney General, 
acting through the director of the Office of Health Information Privacy 
shall have the power to issue subpoenas requiring the attendance and 
testimony of witnesses and the production of any evidence that relates 
to any matter under investigation or in question before the director. 
Such attendance of witnesses and production of evidence at the 
designated place of such hearing, investigation, or other proceeding 
may be required from any place in the United States or in any Territory 
or possession thereof.
            (2) Service.--Subpoenas of the director under paragraph (1) 
        shall be served by anyone authorized by the director by 
        delivering a copy thereof to the individual named therein.
            (3) Proof of service.--A verified return by the individual 
        serving the subpoena under this subsection setting forth the 
        manner of service shall be proof of service.
            (4) Fees.--Witnesses subpoenaed under this subsection shall 
        be paid the same fees and mileage as are paid witnesses in the 
        district court of the United States.
            (5) Refusal to obey.--In case of contumacy by, or refusal 
        to obey a subpoena duly served upon, any person, any district 
        court of the United States for the judicial district in which 
        such person charged with contumacy or refusal to obey is found 
        or resides or transacts business, upon application by the 
        director of the Office of Health Information Privacy, shall 
        have jurisdiction to issue an order requiring such person to 
        appear and give testimony, or to appear and produce evidence, 
        or both. Any failure to obey such order of the court may be 
        punished by the court as contempt thereof.
    (g) Injunctive Relief.--Whenever the director of the Office of 
Health Information Privacy has reason to believe that any person has 
engaged, is engaging, or is about to engage in any activity which makes 
the person subject to a civil monetary penalty under section 321, the 
director may bring an action in an appropriate district court of the 
United States (or, if applicable, a United States court of any 
territory) to enjoin such activity, or to enjoin the person from 
concealing, removing, encumbering, or disposing of assets which may be 
required in order to pay a civil monetary penalty if any such penalty 
were to be imposed or to seek other appropriate relief.
    (h) Agency.--A principal is liable for penalties under section 321 
for the actions of the principal's agent acting within the scope of the 
agency.

SEC. 323. CIVIL ACTION BY INDIVIDUALS.

    (a) In General.--Any individual whose rights under this Act have 
been knowingly or negligently violated may bring a civil action to 
recover--
            (1) such preliminary and equitable relief as the court 
        determines to be appropriate; and
            (2) the greater of compensatory damages or liquidated 
        damages of $5,000.
    (b) Punitive Damages.--In any action brought under this section in 
which the individual has prevailed because of a knowing violation of a 
provision of this Act, the court may, in addition to any relief awarded 
under subsection (a), award such punitive damages as may be warranted.
    (c) Attorney's Fees.--In the case of a civil action brought under 
subsection (a) in which the individual has substantially prevailed, the 
court may assess against the respondent a reasonable attorney's fee and 
other litigation costs and expenses (including expert fees) reasonably 
incurred.
    (d) Limitation.--No action may be commenced under this section more 
than 3 years after the date on which the violation was or should 
reasonably have been discovered.

                        TITLE IV--MISCELLANEOUS

SEC. 401. RELATIONSHIP TO OTHER LAWS.

    (a) Federal and State Laws.--Nothing in this Act shall be construed 
as preempting, superseding or repealing, explicitly or implicitly, 
other Federal or State laws or regulations relating to protected health 
information or relating to an individual's access to protected health 
information or health care services if such laws or regulations provide 
protections for the rights of individuals to the privacy of, and access 
to, their health information that are greater than those provided for 
in this Act.
    (b) Privileges.--Nothing in this Act shall be construed to preempt 
or modify any provisions of State statutory or common law to the extent 
that such law concerns a privilege of a witness or person in a court of 
that State. This Act shall not be construed to supersede or modify any 
provision of Federal statutory or common law to the extent such law 
concerns a privilege of a witness or person in a court of the United 
States. Authorizations pursuant to section 202 shall not be construed 
as a waiver of any such privilege.
    (c) Certain Duties Under Law.--Nothing in this Act shall be 
construed to preempt, supersede, or modify the operation of any State 
law that--
            (1) provides for the reporting of vital statistics such as 
        birth or death information;
            (2) requires the reporting of abuse or neglect information 
        about any individual;
            (3) regulates the disclosure or reporting of information 
        concerning an individual's mental health or communicable 
        disease status otherwise permissible under this Act; or
            (4) governs a minor's rights to access protected health 
        information or health care services.
    (d) Federal Privacy Act.--
            (1) Medical exemptions.--Section 552a of title 5, United 
        States Code, is amended by adding at the end thereof the 
        following: ``The head of an agency that is a health care 
        provider, health plan, health oversight agency, employer, 
        insurer, health or life insurer, school or university, or 
        person who receives protected health information under section 
        211 of the Medical Information Privacy and Security Act shall 
        promulgate rules, in accordance with the requirements 
        (including general notice) of subsections (b)(1), (b)(2), 
        (b)(3), (c), (e) of section 553 of this title, to exempt a 
        system of records within the agency, to the extent that the 
        system of records contains protected health information (as 
        defined in section 4(19) of such Act), from all provisions of 
        this section except subsections (b)(6), (d), (e)(1), (e)(2), 
        subparagraphs (A) through (C) and (E) through (I) of subsection 
        (e)(4), and subsections (e)(5), (e)(6), (e)(9), (e)(12), (l), 
        (n), (o), (p), , (r), and (u).''.
            (2) Technical amendment.--Section 552a(f)(3) of title 5, 
        United States Code, is amended by striking ``pertaining to 
        him,'' and all that follows through the semicolon and inserting 
        ``pertaining to the individual.''
    (e) Constitution.--Nothing in this Act shall be construed to alter, 
diminish, or otherwise weaken existing legal standards under the 
Constitution regarding the confidentiality of protected health 
information.

SEC. 402. EFFECTIVE DATE.

    (a) Effective Date.--Unless specifically provided for otherwise, 
this Act shall take effect on the date that is 12 months after the 
promulgation of the regulations required under subsection (b) but in no 
event later than the date that is 30 months after the date of enactment 
of this Act or 6 months after the promulgation of such regulations, 
whichever is earlier.
    (b) Regulations.--Not later than 12 months after the date of 
enactment of this Act, or as specifically provided for otherwise, the 
director of the Office of Health Information Privacy shall promulgate 
regulations implementing this Act.
                                 <all>
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