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New HIPAA Rules and EHRs: ARRA & Breach Notification - PDF
New HIPAA Rules and EHRs: ARRA & Breach Notification
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1 New HIPAA Rules and EHRs: ARRA & Breach Notification Jim Sheldon-Dean Director of Compliance Services Lewis Creek Systems, LLC and Raj Goel Chief Technology Officer Brainlink International, Inc. 1
2 Today s Objectives Learn about the changes to HIPAA and how they impact the use of EHRs What s in the HIPAA Breach Notification Rule? What are the deadlines and what s my plan? Agenda: I. How ARRA Impacts HIPAA II. Changes to HIPAA Practices III. Implementation Schedule Disclaimer: We are not lawyers and this is not legal advice we are only providing information and resources 2
3 I. Health Information and the Stimulus Package (ARRA) A. Origins of Changes to HIPAA B. New Definitions C. Types of Impacts on HIPAA 3
4 A. Origins of Changes to HIPAA New kinds of entities holding health information Objections to some uses of health information Lack of breach notification for health information Lack of control over business associates Enforcement seen as lacking teeth 4
5 New Law Developed in 2008 Health Information Technology for Economic and Clinical Health Act, or the HITECH Act Under consideration already in 2008 Became Title XIII of the American Recovery and Reinvestment Act of 2009, or ARRA, signed February 17, 2009 Title XIII, Subtitle D-Privacy Definitions: Part 1 Improved Privacy Provisions and Security Provisions: Part 2 Relationship to Other Laws, Regulatory References, Effective Date, Reports:
6 B. New Definitions Breach Electronic Health Record Personal Health Record 6
7 New Definition 13400(1) - Breach Unauthorized acquisition, access, use, or disclosure Compromises privacy or security of PHI Except if info cannot reasonably be retained Does not include unintentional or inadvertent acts by employees or staff in good faith and within scope of job without further acquisition, access, use, or disclosure 7
8 New Definition (5) Electronic Health Record An electronic record of health-related information Created, gathered, managed, and consulted by clinicians and staff 3000(13) Qualified Electronic Health Record Includes patient demographic and clinical health information, such as medical history and problem lists Has the capacity to: Provide clinical decision support Support physician order entry Capture and query information relevant to health care quality Exchange electronic health information from other sources 8
9 New Definition (11) Personal Health Record Electronic record of PHR Identifiable Health Information per 13407(f)(2) Provided by or on behalf of the individual Identifies the individual Drawn from multiple sources Managed by or for the individual e.g. Google Health, Microsoft Health Vault, etc. 9
10 C. Types of Impacts on HIPAA (1 of 2) New kinds of entities covered Business Associates now under HIPAA Personal Health Records Health Information Exchanges New information handling requirements Breach Notification Accounting of Disclosures from EHR Electronic copy of PHI from an EHR 10
11 C. Types of Impacts on HIPAA (2 of 2) New limits on disclosures of PHI To insurers, by request Minimum necessary For sale For marketing New audits, enforcement, and penalties Wrongful disclosures Willful neglect Audits mandated Increased Penalties 11
12 II. Changes to HIPAA Practices A. Breach Notification B. Accounting of Disclosures C. Restriction of Disclosures D. Access to PHI in EHRs 12
13 A. Breach Notification (1 of 5) In ARRA/HITECH: Interim Final Rule published August 23, 2009, effective September 23, 2009, enforceable February 22, 2010 CFR 45 Part 164 Subpart D HIPAA Breach Notification Rule: 164.4xx Co-equal with Privacy and Security Rules Compliance must be integrated with that for State laws must meet requirements of both the stricter rule applies may mean multiple notices Similar law for PHRs under 13407, administered by Federal Trade Commission 13
14 A. Breach Notification (2 of 5) Effective for breaches of unsecured PHI on or after 9/23/ Breach is acquisition, access, use, or disclosure that poses a significant risk of financial, reputational, or other harm to the individual You must make the call on significant risk of harm What is unsecured? Guidance on HHS Web site per ARRA/HITECH 13402(h)(2) Refers to NIST guidance Look for FIPS compliance Old electronic media must be cleared Old hard copies must be unreadable; redaction is excluded 14
15 A. Breach Notification (3 of 5) (a) Notify individual if breach of unsecured information in violation of Privacy Rule Considered discovered on first day known (or should have been) (b) Notify without delay, max 60 days (c) Content of Notice (in plain language) What happened, date of breach and discovery What information was breached What steps the individual should take for protection What the CE is doing about it Investigating the incident Mitigating impacts Protecting against future incidents Contact information Toll free number, and postal address, Web site 15
16 A. Breach Notification (4 of 5) (d) Method of Notice To the individual by mail, or if individual prefers; multiple mailings OK If known to be deceased, to next of kin If no contact info for more than 10, then post on web site home page for 90 days or major media, with toll-free number active for 90 days Contact also allowed by phone if urgent Notification to Media If more than 500 in any jurisdiction, must notify prominent media outlets serving the area Without unreasonable delay, max. 60 days Same content as individual notice 16
17 A. Breach Notification (5 of 5) Notification to Secretary of HHS If over 500, notify HHS when you notify the individuals Secretary of HHS will post >500s on the HHS web site Annual report to Secretary of HHS of ALL breaches BAs must notify CEs Without unreasonable delay, within 60 days Who affected and information needed for contact May delay for Law Enforcement (a) Must comply with Privacy Rule re training, complaints, sanctions, policies, documentation, etc (b) Burden of proof is on CE to show notice was given and any determination of not a breach 17
18 B. Accounting of Disclosures 13405(c): New rules for EHRs Privacy rule has exception for TPO TPO exception for accounting will no longer apply when an EHR is used Accounting of EHR disclosures goes 3 years back Can list disclosures by CE and BA, or list CE disclosures and identify the BAs to ask for an accounting Individuals can ask BAs directly for an accounting Secretary of HHS shall define standards and regulations If using EHR prior to 1/1/09, effective 1/1/2014 If began using EHR after 1/1/09, effective 1/1/
19 C. Restriction of Disclosures 13405(a) Individual may request no disclosure of services to insurer if paid for out of pocket by the individual must comply effective 2/17/10 EHR will need to track any such services 19
20 D. Access to PHI in EHRs 13405(e) Individual may request electronic copy of EHR information effective 2/17/10 How will this be provided? Readable, understandable Delivery method? Encryption? 20
21 III. Implementation Schedule A. Sections in Effect Immediately B. Sections in Effect During 2009 C. Sections in Effect 2/17/2010 D. Longer-term Deadlines E. Your to-do list 21
22 A. Sections in Effect Immediately Higher Penalties $100 - $50,000 per instance, for unintentional, unpreventable violations $ $50,000 per instance, for reasonable cause but not willful neglect $10,000 - $50,000 per instance, for willful neglect that is corrected At least $50,000 per instance for willful neglect that is not corrected Up to $25K to $1.5 million per year for all violations of the same type State Attorneys General may enforce HIPAA 22
23 B. Sections in Effect During 2009 Breach Notification Interim final rule effective September 23, 2009 Log all breaches beginning 9/23/2009, for report on 2009 due March 1, 2010 Guidance issued by HHS April 17, 2009, available on the HHS Web site FTC regulation for PHR breach notification issued August 17,
24 C. Sections in Effect 2/17/2010 February 17, 2010 Business Associates covered by HIPAA HIEs, RHIOs, etc. become BAs Restriction of disclosure to insurers Disclose only minimum necessary Guidance on de-identification due Providing copy of EHR in electronic format Marketing limitations Wrongful Disclosures penalties in effect Audits of HIPAA compliance by HHS under way 24
25 D. Longer-term Deadlines February 22, 2010: Breach rule enforceable March 1, 2010: 2009 Breach log due at HHS August 17, 2010 Regulations on sales of PHI due, eff. 6 months later Regulations on Willful Neglect due, eff. 6 months later Guidance on minimum necessary due January 1, 2011 If began using EHR after 1/1/09, must be able to provide accounting of disclosures including TPO January 1, 2014 If began using EHR before 1/1/09, must be able to provide accounting of disclosures including TPO 25
26 E. Your to-do list Don t be in denial willful neglect will cost you Establish good information security practices as required by the HIPAA Security Rule Start developing your breach notification policy and plans now you should have this for state laws and the FTC Red Flags Rule as well and start logging breaches now Be ready by February 2010 for: restriction of disclosures to insurers electronic copy of PHI from EHR compliance with HIPAA Breach Notification Rule increased HHS audits 26
27 Thank you! Any Questions? For additional information, please contact: Jim Sheldon-Dean, Lewis Creek Systems, LLC and Raj Goel, Brainlink International, Inc Resources, regulations, laws, guidance, and tools at: 27
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