American Health Lawyers Association State Law Landscape for Health Information Technology
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1 American Health Lawyers Association State Law Landscape for Health Information Technology August 9, 2017 Cason D. Schmit, J.D. Texas A&M University, School of Public Health Department of Health Policy and Management, College Station, TX This webinar is sponsored by
2 Acknowledgements Public Health Law Program Office for State, Tribal, Local and Territorial Support U.S. Centers for Disease Control and Prevention Gregory Sunshine, J.D. Dawn Pepin, J.D., M.P.H. Tara Ramanathan, J.D., M.P.H. Akshara Menon, J.D., M.P.H. Matthew Penn, J.D., M.L.I.S. Sarah Wetter, J.D. Bita Kash, Ph.D., M.B.A., FACHE
3 Objectives Describe the national landscape of state laws regulating health information Explore the implications and effects of persistent misconceptions of legal barriers to data use Discuss some moral, economic, social and political factors, that may be relevant to your client's situation.
4 Advising Clients Model Rules for Professional Conduct Rule 2.1 Advisor In representing a client, a lawyer shall exercise independent professional judgment and render candid advice. In rendering advice, a lawyer may refer not only to law but to other considerations such as moral, economic, social and political factors, that may be relevant to the client's situation. nduct/rule_2_1_advisor.html
5 Fungal Meningitis Outbreak 2012 Healthcare associated infection 753 total cases 64 deaths 20 states Outbreak revealed critical issues relating to releasing of health information
6
7 Identifying Real and Perceived Legal Barriers Public health officials consistently reported perceived HIPAA barriers as a reason healthcare facilities were hesitant to provide health departments with access to patient information.
8 HIPAA Public Health Exception (1) Permitted uses and disclosures. A covered entity may use or disclose protected health information for the public health activities and purposes described in this paragraph to: (i) A public health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions; or, at the direction of a public health authority, to an official of a foreign government agency that is acting in collaboration with a public health authority; 45 C.F.R (b)
9 Identifying Real and Perceived Legal Barriers Making sure that [facilities and providers] have an understanding of their state privacy laws and obviously the federal side of it. That is the biggest issue that we run into. - Health department staff
10 Reviews of State Laws Protecting Health Information a morass of erratic law (HIPAA) Workgroup for Electronic Data Interchange, Report to Secretary of U.S. Department of Health and Human Services, Appendix 4 (1992), (available at Harmonizing State Privacy Law Collaborative, Update to October 9, 2007 Report on State Privacy & Security Laws Related to Electronic Health Records and Electronic Health Information Exchange (2008), (available at C. Schmit, G. Sunshine, D. Pepin, T. Ramanathan, A. Menon, M. Penn, Transitioning from Paper to Digital: State Statutory and Regulatory Frameworks for Health Information Technology. Public Health Rep. in press (2017).
11 a morass of erratic law Reviews of State Laws Protecting Health Information fragmented and outdated state laws as a significant barrier to health information exchange (HIPAA) (HITECH & ACA) Workgroup for Electronic Data Interchange, Report to Secretary of U.S. Department of Health and Human Services, Appendix 4 (1992), (available at Harmonizing State Privacy Law Collaborative, Update to October 9, 2007 Report on State Privacy & Security Laws Related to Electronic Health Records and Electronic Health Information Exchange (2008), (available at C. Schmit, G. Sunshine, D. Pepin, T. Ramanathan, A. Menon, M. Penn, Transitioning from Paper to Digital: State Statutory and Regulatory Frameworks for Health Information Technology. Public Health Rep. in press (2017).
12 Reviews of State Laws Protecting Health Information a morass of erratic law fragmented and outdated state laws as a significant barrier to health information exchange. The large quantity and diversity of laws complicate legal analysis, likely delay implementation of public health solutions, and might be detrimental to the development of emerging health information technology (HIPAA) (HITECH & ACA) 2017 Workgroup for Electronic Data Interchange, Report to Secretary of U.S. Department of Health and Human Services, Appendix 4 (1992), (available at Harmonizing State Privacy Law Collaborative, Update to October 9, 2007 Report on State Privacy & Security Laws Related to Electronic Health Records and Electronic Health Information Exchange (2008), (available at C. Schmit, G. Sunshine, D. Pepin, T. Ramanathan, A. Menon, M. Penn, Transitioning from Paper to Digital: State Statutory and Regulatory Frameworks for Health Information Technology. Public Health Rep. in press (2017).
13 Evaluating State Laws Regulating Electronic Health Information What we did Identified relevant legal provisions using Westlaw legal database Only includes laws in effect as of January 2014 Categorized legal provisions by the nature of electronic health information use described in the law What we found States have passed numerous laws addressing electronic health information: 2,364 statutes and regulations 49 different regulated uses State legal frameworks are diverse and vary qualitatively and quantitatively C. Schmit, G. Sunshine, D. Pepin, T. Ramanathan, A. Menon, M. Penn, Transitioning from Paper to Digital: State Statutory and Regulatory Frameworks for Health Information Technology. Public Health Rep. in press (2017).
14 Uses of Electronic Health Information Regulated by Laws in effect January 2014
15 Number of laws relating to Electronic Health Information in effect January 2014 (all states).
16 State Health Information Exchange (HIE) Laws
17 HIE Oversight Entity (2016) State entity with oversight responsibilities for the HIE Yes (31) Preliminary data from a study of Health Information Exchange Laws
18 HIE Oversight Entity (2016) State entity with oversight responsibilities for the HIE Yes (31) At least 11 oversight entities within 300 miles of New Jersey
19 State Entity HIE Rule-Making (HIE) State entity authorized to promulgate rules and regulations pertaining to the HIE Yes (23) Preliminary data from a study of Health Information Exchange Laws
20 HIE Consent Model (2016) State entity with oversight responsibilities for the HIE Opt-in (8*) Opt-out (15) Voluntary/not specified (2) Ambiguous (2**) Preliminary data from a study of Health Information Exchange Laws * - Includes California Demonstration HIE legislation ** - Coded Ambiguous if law could either satisfy the coding criteria or not, depending on differing reasonable interpretations of the terms of the law.
21 Actual and Perceived Legal Barriers to Data Use and Release There are many perceived legal barriers to data use and release Not all are actual legal prohibitions Three approaches to perceived barriers Apply conservative data use policies Identify legal solutions Identify technological solutions Clients need an understanding of underlying legal framework
22 Future Applications of HIT Future HIT applications require data portability!!! Mobile medicine Precision medicine Learning health systems Health care will rely heavily on big data in the future
23 A. B. Martin, M. Hartman, B. Washington, A. Catlin, the N. H. E. A. National Health Expenditure Accounts Team, National Health Spending: Faster Growth In 2015 As Coverage Expands And Utilization Increases. Health Aff. (Millwood). 36, (2017).
24 In 2015, healthcare spending amounted to 17.8% of the GDP A. B. Martin, M. Hartman, B. Washington, A. Catlin, the N. H. E. A. National Health Expenditure Accounts Team, National Health Spending: Faster Growth In 2015 As Coverage Expands And Utilization Increases. Health Aff. (Millwood). 36, (2017).
25 Title 2017 is published by the American Health Lawyers Association. All rights reserved. No part of this publication may be reproduced in any form except by prior written permission from the publisher. Printed in the United States of America. Any views or advice offered in this publication are those of its authors and should not be construed as the position of the American Health Lawyers Association. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is provided with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional person should be sought from a declaration of the American Bar Association.
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