HIPAA & HEALTH INFORMATION EXCHANGE
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1 HIPAA & HEALTH INFORMATION EXCHANGE (Perspective from the Private Sector) Helen Oscislawski, Esq. March 26, th National HIPAA Summit Washington D.C Oscislawski LLC Where Should We Start? Privacy & Security with Health Information Exchange
2 HIPAA & HITECH * State Law considerations too Notice of Privacy Practices (Privacy Rule) Permitted Uses & Disclosures (Privacy Rule)* Authorization & Consent (Privacy Rule)* Patient Access Rights (Privacy Rule/HITECH)* Accounting of Disclosures (Privacy Rule/HITECH) Preemption (HIPAA/Privacy Rule) Role-Based Access (Security Rule) Authentication (Security Rule) Auditing (Security Rule) Breach Notification (HITECH)* Security Gap Assessment (Security Rule) Complaints & Sanctions (Privacy/Security Rules) HIPAA BA Agreements (Privacy/Security/HITECH) ONC Guiding Principles for HIE privacy security_framework/1173 Openness & Transparency Individual Choice Collection, Use & Disclosure Limitation Safeguards Data Quality & Integrity Correction Accountability Individual Access
3 CROSSWALKING HIE GUIDING PRINCIPLES with HIPAA HIE Policies (1-20) 1. Compliance with National Privacy and Security Framework 2. Table of Contents and Definitions 3. Governance 4. Patient Rights 5. Patient Participation and Choice 6. Participants and Authorized Users 7. Security Risk Assessment 8. Authorization and Access 9. Authentication 10. Compliance with Laws & Policies 11. Notice of Privacy Practices 12. Permitted and Prohibited Uses and Disclosures 13. Information Subject to Special Protection 14. Minimum Necessary 15. Business Associates 16. Security Incidents & Breaches 17. Auditing 18. Data Integrity and Correction 19. Complaints 20. Enforcements and Sanctions
4 New Jersey Sequestration Pilot Exchange Type: Hospital-based Governance: - HIE Council - Physician Usage Committee - Privacy & Security Committee Technology: - Centralized HIE (Wellogic) - Plug-in for tagging sensitive data the sequestration safeguard (EnableCare) Consent Model: Opt-Out as baseline for hospital and basic providers Opt-In for sensitive provider-types Episodic consent for tagged/sequestered data Consent Models for HIE* No Consent Opt-Out Opt-Out, with Granularity of Choice Opt-In Opt-In, with Granularity of Choice * Consumer Consent Options for Electronic Health Information Exchange: Policy Considerations and Analysis, Department of Health Policy, School of Public Health and Health Services, George Washington University medical Center (March 23, 2010).
5 Approaches Considered by NJ Pilot No restrictions on sharing, including sensitive information. Concern is patient trust and comfort with a system that treats all information the same; it s not. One for All. Concerns that if the consent covers everything, still does not offer true confidentiality for patient, especially for sensitive data. Also prone to sign here blanket approach, which is not meaningful. Item-by-item restriction (granularity). Although this increases patient control, very, very difficult to administer. Also, too much choice is not always a good thing patients may forget previous preferences, may be too cumbersome for even the patient. Also not in line with current workflows where information is already being exchanged. * Data Segmentation in Electronic Health Information Exchange: Policy Considerations and Analysis, Department of Health Policy, School of Public Health and Health Services, George Washington University medical Center (September 29, 2010). Why Sequestration? Balances Medical Need & Privacy Interests
6 What on Earth is Sequestration? February 20, 2008 Letter -the National Committee on Vital and Health Statistics (NCVHS) first used the term in its letter to then-secretary of the U.S. Department of Health, Michael O. Leavitt. The Letter says on page 3: NCVHS recommends permitting an individual to sequester sensitive information based on predefined categories of information as defined below. Every individual would have the option of designating one or more categories for sequestering. If a category is selected, all of the information in that category, as the category is defined, would be sequestered. The individual would not have the option of selecting only specific items within that category to sequester (an approach discussed below that we rejected. (emphasis added). NCVHS 2008 Recommendations 1.a. Patients should be permitted to sequester specific sections of their health record in one or more pre-defined categories. 1.b. HHS should initiate an open, transparent, and public process to identify the possible categories of sensitive information for sequestration, and to defined with specificity the criteria for inclusion and exclusion within each category. 1.c. Categories of information that are sequestered should be notated that certain information is sequestered patient s request 1.d. Design should permit individuals ability to authorize selected health care providers to access sequestered information. 1.e. Emergency access should be permitted, 1.f. Audit trails must capture all break glass episodes. 1.g. Patient must be notified of break glass situations 1.h. Provider who accesses the information is responsible for ensuring that information is either re-sequestered or otherwise further disclosed only as permitted by applicable law.
7 HITECH Segmentation February 2009, HITECH Act (H.R. 1) includes 3002(b)(2)(B) which specifically directs the HIT Policy Committee (at ONC) to make recommendations for: technologies that protect the privacy of health information and promote security in a qualified electronic health record, including for the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of patients to seek care (or disclose information about a condition) because of privacy concerns, in accordance with applicable law (emphasis added). HITECH on NCVHS Recommendations Section 3002(b)(8) of the HITECH Act then goes on to require that: The National Coordinator shall ensure that the relevant and available recommendations and comments from the National Committee on Vital and Health Statistics are considered in the development of policies.
8 NCVHS November 2010 Recommendations November 10, 2010 Letter - NCVHS issues second letter to DHHS Secretary with Recommendations Regarding Sensitive Health Information. Provides suggested categories of sensitive information: Federal law HIPAA Psychotherapy Notes HITECH Out of pocket services 42 CFR Part 2 GINA State law: HIV/AIDS; STDs; Genetic; Mental Health; Emancipated Minors Other : Mental Health Sexuality and Reproductive Health Domestic Violence NJ Pilot Defining What is Sensitive FEDERAL: 42 CFR Part 2 Records; GINA (Genetic Information and Nondisclosure Act) Services paid for out of pocket (HITECH) Psychotherapy Notes as defined under HIPAA, disclosure requires prior written authorization of the individual STATE: HIV/AIDS Information (N.J.S.A. 26:5C-8) Venereal Diseases (N.J.S.A. 26:4-41) Drug & Alcohol Rehabilitation Information (N.J.S.A. 26:2B-8) Mental Health Rehabilitation (N.J.A.C 10: ) Genetic Privacy Act of New Jersey (N.J.S.A. 10:5-43) Minor s Emancipated Treatment (N.J.S.A. 9:17B-1) Social Security Numbers. NCVHS Recommendations Reproductive Rights Domestic Violence
9 Initial Numbers* Total reports analyzed: 1,663,730 (all hospital and ED) Reports by Type: Anatomic Pathology: 50,011 Radiology: 636,012 ED visits 463,701 History and Physical 77,078 Discharge Summary 88,598 Consults 97,121 Operative Report 57,701 Other 193,508 (cardiology, surgery, L&D) * Based on preliminary testing and analysis. Numbers do not necessarily reflect final results. Initial Numbers*. Total with multiple sensitive flags: 1.2% Total with one sensitive category: 3.4% Total Sensitive: 4.6% Total with negated vocabulary: 3.5% (sensitive terms with negation language e.g. not, no evidence of, ) (not included in the sensitive % above) * Based on preliminary testing and analysis. Numbers do not necessarily reflect final results.
10 Initial Numbers*. Sensitive Data Tagged by Category (per rules): Abortion 3.8% Genetic testing/diseases 11.4% HIV 6.1% of sensitive Mental health treatment 6.9% Sexual abuse (minors) 0.2% Sexual activity (minors) 8.2% Sexually Transmitted Diseases 18.4% Substance abuse (minors) 0.7% Suicidal ideation 44.3% * Based on preliminary testing and analysis. Numbers do not necessarily reflect final results. Why Sequestration? Balancing Competing Interests Benefits of EHR Individual Control Longitudinal, comprehensive, vs. Electronic health information and interoperable EHR exchange (HIE) is a major shift presents opportunities for from decentralized, enhancing coordination of disconnected, largely paperbased care, avoiding duplication of services, and improving the health record system currently in use. There are effectiveness and efficiency significant implications for of health care. Also makes it individual privacy and possible for all health care confidentiality. If HIE networks providers who may be do not afford some level of consulted to have access to protection, privacy could be an individuals EHR from all compromised and patients current and past providers. may resist participating.
11 Questions? Helen Oscislawski, Esq. Principal, Attorneys at Oscislawski LLC HIE Blog: HIE, HIPAA & HITECH Legal Forms:
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