The Impact of the New HIPAA Omnibus Final Rule - Q&A Session

This session will give you an exceptional opportunity to hear from and ask questions of Susan McAndrew, HHS Office of Civil Rights Deputy Director, about the recently released “omnibus” HIPAA Final Rule. The Rule finalized the changes made to the Privacy, Security, Breach Notification, and Enforcement Rules called for by the HITECH Act of 2009 and the Genetic Information Nondiscrimination Act of 2008. Building on AMIA’s earlier webinar which provided an overview of the entire Rule, this session will do a deep dive on the impact of the Rule on clinical and information-based research. We will then have an extensive period of time for you to submit questions to Ms. McAndrew about the effects of the Rule on research, Covered Entities, Business Associates, and patient rights. This session is intended for healthcare professionals, researchers and others who need to know about the Omnibus Rule and don’t want to miss the chance to pose their questions to a leading regulator responsible for enforcing the Rule.

Learning Objectives

• Changes to HIPAA to align it more with the Common Rule governing human subject research
• Potential new impediments to information-based research
• The significant expansion of the reach of HIPAA regulations to new Business Associates
• New provisions regarding Covered Entities’ duties to honor new patient rights to access and control their PHI
• Breach notices and limits on the use and disclosure of PHI

Speakers Information

Susan McAndrew is the Deputy Director for Health Information Privacy (HIP), Office for Civil Rights (OCR) at the US Department of Health and Human Services (HHS). As Deputy Director, Ms. McAndrew has responsibility for implementing and enforcing the Privacy Rule and the Security Rule issued pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Ms. McAndrew has worked primarily on the HIPAA Privacy Rule for HHS since May 2000 and is the senior advisor to the Director for OCR on privacy and security matters. Since the enactment of the HITECH Act in 2009, the HIP Division has been responsible for implementation and enforcement of those provisions, including breach notification and piloting an audit program. Ms. McAndrew has over 25 years of federal government experience; received her J.D. from Georgetown University Law Center and, prior to joining HHS, practiced law in the District of Columbia, including twelve years at Wilmer, Cutler & Pickering (now WilmerHale).

Douglas Peddicord, Ph.D., is President of Washington Health Strategies Group (WHSG), LLC. WHSG provides a full range of consulting, lobbying and association management services to various clients and has provided services to AMIA for more than ten years. Previously, Doug was a partner in Oldaker, Belair & Wittie and Vice President of Washington Health Advocates, representing physician and patient groups, health systems, and professional societies. Following a career as a clinical psychologist, Dr. Peddicord came to Capitol Hill in 1994 as an American Association for the Advancement of Science (AAAS) Fellow. Currently, he provides strategic and policy advice and representation to health care organizations on matters including Medicare coverage and payment policy, health information technologies and medical privacy, and drug development activities.

Ann Waldo, JD, CIPP, is a Partner in the law firm of Wittie, Letsche & Waldo, LLP, providing legal counsel, public policy, and government advocacy on privacy, information management, and health policy. She focuses on HIPAA/HITECH and consumer health privacy and is particularly interested in novel issues involving heath information exchange, innovation, and health information technology. She was also the Chief Privacy Officer at Hoffmann-La Roche, handling privacy compliance and best practices in marketing, HIPAA, and clinical research. She is a Certified Information Privacy Professional. She has counseled a state Health Information Exchange and has been an advisor to the Office of the National Coordinator on Health Information Technology (ONC) evaluating grant recipients. She currently serves on the Advisory Board for the Harvard SHARP information technology grant.