Protecting Personal Health Data Act
Bill: S.24 | Sponsor: Sen. Klobuchar, Amy (D-MN)
Policy area: Health

Summary:
Protecting Personal Health Data Act
This bill directs the Department of Health and Human Services to regulate consumer devices, services, applications, and software that (1) are primarily designed for or marketed to consumers; (2) primarily collect or use personal health data; and (3) are not primarily designed for use by entities such as health care plans, providers, or clearinghouses.
The bill also establishes a national task force on health data protection.

To protect the personal health data of all Americans.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Personal Health Data 
Act''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) On July 19, 2016, the Department of Health and Human 
        Services, acting through the Office of the National Coordinator 
        for Health Information Technology and in coordination with the 
        Office for Civil Rights of the Department of Health and Human 
        Services and the Federal Trade Commission, issued a report to 
        Congress entitled ``Examining Oversight of the Privacy & 
        Security of Health Data Collected by Entities Not Regulated by 
        HIPAA'' (referred to in this section as the ``report'') about 
        the need to enact modern protections for consumers' personal 
        health data.
            (2) The report states that ``[t]he wearable fitness 
        trackers, social media sites where individuals share health 
        information through specific social networks, and other 
        technologies that are common today did not exist when Congress 
        enacted the Health Insurance Portability and Accountability Act 
        of 1996''.
            (3) The report states that entities not covered by the 
        privacy protections of the Health Insurance Portability and 
        Accountability Act of 1996 (Public Law 104-191), such as 
        wearable fitness trackers and health-focused social media 
        sites, ``engage in a variety of practices such as online 
        advertising and marketing, commercial uses or sale of 
        individual information, and behavioral tracking practices, all 
        of which indicate information use that is likely broader than 
        what individuals would anticipate''.
            (4) The report ``identifies key gaps that exist between 
        HIPAA regulated entities and those not regulated by HIPAA'' and 
        ``recommends addressing those gaps in a way that protects 
        consumers while leveling the playing field for innovators 
        inside and outside of HIPAA''.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Consumer devices, services, applications, and 
        software.--
                    (A) In general.--Except as provided in subparagraph 
                (C), the term ``consumer devices, services, 
                applications, and software'' means devices, services, 
                applications, and software--
                            (i) that are primarily designed for or 
                        marketed to consumers; and
                            (ii) a substantial purpose or use of which 
                        is to collect or use personal health data.
                    (B) Inclusion.--The term ``consumer devices, 
                services, applications, and software'' shall include, 
                but is not limited to--
                            (i) direct-to-consumer genetic testing 
                        services;
                            (ii) cloud-based or mobile technologies 
                        that are designed to collect individuals' 
                        personal health data directly or indirectly 
                        with individuals' consent, which could enable 
                        sharing of such information, such as wearable 
                        fitness trackers; and
                            (iii) internet-based social media sites 
                        which are primarily designed for, or marketed 
                        to, consumers to collect or use personal health 
                        data, including sites that share health 
                        conditions and experiences.
                    (C) Exception.--The term ``consumer devices, 
                services, applications, and software'' shall not 
                include--
                            (i) products on which personal health data 
                        is derived solely from other information that 
                        is not personal health data, such as Global 
                        Positioning System data; or
                            (ii) products primarily designed for, or 
                        marketed to, covered entities and business 
                        associates (as defined for purposes of 
                        regulations promulgated under section 264(c) of 
                        the Health Insurance Portability and 
                        Accountability Act of 1996 (42 U.S.C. 1320d-2 
                        note)).
            (2) Direct-to-consumer genetic testing services.--The term 
        ``direct-to-consumer genetic testing service'' means a service, 
        which may include a test that analyzes various aspects of an 
        individual's genetic material, that enables a consumer to have 
        access to their genetic information, or to information derived 
        therefrom, without the need to have a health care provider or 
        health insurance issuer participate in the process of gaining 
        access.
            (3) National coordinator.--The term ``National 
        Coordinator'' means the National Coordinator for Health 
        Information Technology at the Department of Health and Human 
        Services.
            (4) Operator.--The term ``operator'' means any person who 
        operates any type of consumer devices, services, applications, 
        and software or who provides consumer devices, services, 
        applications, and software for the use of consumers and 
        collects or maintains personal health data from or about the 
        users of such consumer devices, services, applications, and 
        software.
            (5) Personal health data.--The term ``personal health 
        data'' means any information, including genetic information, 
        whether oral or recorded in any form or medium, that relates to 
        the past, present, or future physical or mental health or 
        condition of an individual and that identifies the individual 
        or with respect to which there is a reasonable basis to believe 
        that the information can be used to identify the individual.
            (6) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

SEC. 4. PROMULGATION OF REGULATIONS FOR OPERATORS OF CONSUMER DEVICES, 
              SERVICES, APPLICATIONS, AND SOFTWARE.

    (a) In General.--Not later than 6 months after the date on which 
the report is submitted under section 5(d), the Secretary, in 
consultation with the Chairman of the Federal Trade Commission, the 
National Coordinator, relevant stakeholders, and heads of such other 
Federal agencies as the Secretary considers appropriate, shall 
promulgate regulations to help strengthen privacy and security 
protections for consumers' personal health data that is collected, 
processed, analyzed, or used by consumer devices, services, 
applications, and software.
    (b) Requirements.--
            (1) In general.--The Secretary shall ensure that the 
        regulations pursuant to subsection (a)--
                    (A) account for differences in the nature and 
                sensitivity of the data collected or stored on the 
                consumer device, service, application, or software; and
                    (B) include such definitions for relevant terms 
                that are necessary to accomplish the goals of the 
                regulations set forth in subsection (a).
            (2) Requirements of secretary.--In the promulgation of 
        regulations under subsection (a), the Secretary, to the extent 
        practicable, shall--
                    (A) consider the findings in the report issued by 
                the Department of Health and Human Services to Congress 
                entitled ``Examining Oversight of the Privacy & 
                Security of Health Data Collected by Entities Not 
                Regulated by HIPAA'', including findings regarding 
                individuals' access rights, re-use of data by third 
                parties, security standards applicable to data holders 
                and users, confusion or ambiguity regarding terminology 
                related to privacy and security protections, and the 
                adequacy of collection, use, and disclosure 
                limitations;
                    (B) consider other regulations and guidance issued 
                by the Federal Trade Commission, and other regulations 
                promulgated under section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996 
                (42 U.S.C. 1320d-2 note), subtitle D of the Health 
                Information Technology for Economic and Clinical Health 
                Act (42 U.S.C. 17921 et seq.), Genetic Information 
                Nondiscrimination Act (Public Law 110-233, 122 Stat. 
                881), the Common Rule as contained in part 46 of title 
                45, Code of Federal Regulations, and other related 
                Acts;
                    (C) consistent with paragraph (3), consider 
                appropriate uniform standards for consent related to 
                the handling of genetic data, biometric data, and 
                personal health data;
                    (D) consider exceptions to consent requirements 
                under subparagraph (C) for purposes that may include 
                law enforcement, academic research or research for the 
                sole purpose of assessing health care utilization and 
                outcomes, emergency medical treatment, or determining 
                paternity;
                    (E) consider appropriate minimum standards of 
                security that may differ according to the nature and 
                sensitivity of the data collected or stored on, or 
                processed or transferred by, the consumer device, 
                service, application, or software;
                    (F) consider appropriate standards for the de-
                identification of personal health data;
                    (G) consider appropriate limitations on the 
                collection, use, or disclosure of personal health data 
                to that which is directly relevant and necessary to 
                accomplish a specified purpose;
                    (H) consult with the National Coordinator, the 
                Commissioner of Food and Drugs, and the Chairman of the 
                Federal Trade Commission; and
                    (I) provide for initial and ongoing outreach 
                regarding regulations affecting industries, businesses, 
                and individuals to ensure awareness of consumer privacy 
                and security protections in the field of digital health 
                technology.
            (3) Uniform standards.--In the review of each of the areas 
        described in paragraph (2)(C), the Secretary shall consider--
                    (A) the development of standards for obtaining user 
                consent based on how information will be shared to 
                ensure that prior to the collection, analysis, use, or 
                disclosure of consumers' personal health data, an 
                operator of a consumer device, service, application, or 
                software specifies the uses of the personal health data 
                and who will have access to the information;
                    (B) the manner in which consent is obtained in a 
                way that uses clear, concise, and well-organized 
                language that is easily accessible, of reasonable 
                length, at an appropriate level of readability, and 
                clearly distinguishable from other matters;
                    (C) a process to limit the transfer of personal 
                health data to third parties and provide consumers with 
                greater control over how their personal health data is 
                used for marketing purposes;
                    (D) secondary uses outside of the primary purpose 
                of the service as initially indicated when consent was 
                first obtained;
                    (E) a process to permit a withdrawal of consent to 
                ensure that a user is able to remove consent for the 
                terms of service for use of the consumer device, 
                service, application, or software, including the 
                collection and use of personal health data as easily as 
                the user is able to give such consent;
                    (F) providing a right to access a copy of the 
                personal health data that the operator has collected, 
                analyzed, or used, free of charge and in an electronic 
                and easily accessible format, including a list of each 
                entity that received the personal health data from the 
                operator, whether through sale or other means; and
                    (G) providing a right to delete and amend personal 
                health data, to the extent practicable, that the 
                operator has collected, analyzed, or used.
    (c) Updates.--The Secretary shall review and, if necessary, update 
the regulations promulgated under subsection (a) in accordance with the 
requirements under subsection (b).
    (d) Public Availability.--The Department of Health and Human 
Services shall make prominently available to the public on the 
Department's internet website, clear and concise information about 
available resources related to the regulations promulgated under 
subsection (a) and all updates to such resources.
    (e) Consistency of Resources Published by Federal Agencies.--If a 
Federal agency publishes resources to help protect consumers' personal 
health data, the head of such Federal agency, to the degree 
practicable, shall make such resources consistent with the regulations 
promulgated under subsection (a).
    (f) Other Federal Privacy and Security Requirements.--Nothing in 
this section shall be construed to supersede, alter, or otherwise 
affect any privacy and security requirements enforced by Federal 
agencies.

SEC. 5. NATIONAL TASK FORCE ON HEALTH DATA PROTECTION.

    (a) Establishment.--The Secretary, in consultation with the 
Chairman of the Federal Trade Commission, the National Coordinator, and 
relevant stakeholders, shall establish a task force, to be known as the 
National Task Force on Health Data Protection (referred to in this 
section as the ``Task Force'').
    (b) Duties.--The Task Force shall--
            (1) study the long-term effectiveness of de-identification 
        methodologies for genetic data and biometric data;
            (2) evaluate and provide input on the development of 
        security standards, including encryption standards and transfer 
        protocols, for consumer devices, services, applications, and 
        software;
            (3) evaluate and provide input with respect to addressing 
        cybersecurity risks and security concerns related to consumer 
        devices, services, applications, and software;
            (4) evaluate and provide input with respect to the privacy 
        concerns and protection standards related to consumer and 
        employee health data;
            (5) review and advise on the need, if any, to update the 
        report issued by the Department of Health and Human Services to 
        Congress entitled ``Examining Oversight of the Privacy & 
        Security of Health Data Collected by Entities Not Regulated by 
        HIPAA''; and
            (6) provide advice and consultation in the establishment 
        and dissemination of resources to educate and advise consumers 
        about the basics of genetics and direct-to-consumer genetic 
        testing, and the risks, benefits, and limitations of such 
        testing.
    (c) Members.--The Secretary, in consultation with the Chairman of 
the Federal Trade Commission, the National Coordinator, and relevant 
stakeholders, shall appoint not more than 15 members to the Task Force. 
In appointing such members, the Secretary shall ensure that the total 
membership of the Task Force is an odd number and represents a diverse 
set of stakeholder perspectives.
    (d) Reporting.--Not later than 1 year after the date of enactment 
of this Act, the Task Force shall prepare and submit to the Committee 
on Commerce, Science, and Transportation of the Senate, the Committee 
on Health, Education, Labor, and Pensions of the Senate, the Committee 
on Homeland Security and Governmental Affairs of the Senate, the 
Committee on Energy and Commerce of the House of Representatives, the 
Committee on Homeland Security of the House of Representatives, the 
Secretary, the Chairman of the Federal Trade Commission, and the 
Commissioner of Food and Drugs, a report on the findings of the Task 
Force.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section.
    (f) Federal Advisory Committee Act.--The Federal Advisory Committee 
Act (5 U.S.C. App.) shall apply to the Task Force.
    (g) Sunset.--
            (1) In general.--The Task Force shall terminate on the date 
        that is 5 years after the date of the first meeting of the Task 
        Force.
            (2) Recommendation.--Not later than the date that is one 
        year prior to the termination of the Task Force under paragraph 
        (1), the Secretary shall submit to Congress a recommendation on 
        whether the Task Force should be extended.
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