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Expanding Medical Research Opportunities: Proposed 21st Century Cures Act Offers Increased Access to Health Information

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DESCRIPTION

When the Department of Health and Human Services (HHS) adopted its omnibus revisions to the regulations implementing the Heath Insurance Portability and Accountability Act (HIPAA) in 2013, it relaxed slightly the HIPAA Privacy Rule restrictions on disclosures of ‘‘protected health information’’ (PHI) for purposes of research. As HHS acknowledged at the time, it had received numerous comments from researchers and others since adopting the Privacy Rule in 2000 that its restrictions on uses and disclosures of PHI were hamstringing valuable and important research opportunities. In the views of some Members of Congress, the 2013 revisions fell short of what is needed to realize such opportunities, particularly given new technological and other tools that promise in many ways to revolutionize health care in the current century.

As a move toward more substantial changes, the House Energy and Commerce Committee has proposed provisions, as part of the Committee’s draft ‘‘21st Century Cures Act’’ released earlier this year that would further open up access to PHI for research purposes. Those provisions, contained in Section 2221 of the draft Cures Act, would amend the Privacy Rule to enable researchers to obtain PHI more easily from HIPAA ‘‘covered entities’’ (primarily health care providers and health insurance plans) and to use PHI for a broader range of research. As described in the Committee’s summary of the draft legislation, these changes would ‘‘unlock the research potential of data siloed in health care facilities across the country and enable patients who want to play a more proactive role in finding better treatments or a cure for their disease to do so in a responsible manner that continues to protect their privacy.

Educational Objectives:
•Review the background on research under the Heath Insurance Portability and Accountability Act (HIPAA) Privacy Rule
•Discuss disclosure of limited data sets without data use agreements
•Explore the new draft of the 21st Century Cures Act
•Analyze remote access to protected health information’’ preparatory to research
•Explain disclosures to public health-related research and HIPAA covered entities and business associates

Who would benefit most from attending this program?
This webinar will be useful to anyone who wants to get up to speed on the proposed 21st Century Cures Act; including practitioners that advise employers on benefits matters.

SPEAKERS

NANCY L. PERKINS, COUNSEL, ARNOLD & PORTER LLP

Nancy L. Perkins is counsel at Arnold & Porter LLP. She focuses her practice on litigation, regulatory compliance, and consulting on emerging policy issues, with a principal focus on data privacy and security. She regularly advises clients on compliance with a wide range of data protection requirements at the federal and state levels, including rules applicable to online communications and transactions as well as all types of uses and disclosures of medical, financial, and other sensitive personal information. She assists clients in structuring their activities, online service offerings and privacy policies to comply with applicable laws and best practices, taking into account technological and intellectual property issues associated with the expansion of electronic commerce and Internet activities. Among other laws, Ms. Perkins frequently provides counsel on the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act, the Gramm-Leach-Bliley Act, the Fair Credit Reporting Act (as amended by the Fair and Accurate Credit Transactions Act), the federal E-Sign Act, the Children's Online Privacy Protection Act, and the Video Privacy Protection Act,  - as well as state privacy, security, data breach notification, and electronic signature laws. She also has a deep background in international law and advises clients on the US-EU Safe Harbor relating to the EU Data Protection Directive, as well as broader issues arising under the rapidly developing framework for global legal protection of personal information. She is a member of the District of Columbia bar.