What Should Innovation Policy Look Like?

The ACC hosted a roundtable on Nov. 30 focused on identifying hurdles to research and innovation in cardiovascular care. Co-chaired by former ACC President Patrick O'Gara, MD, MACC, and William Borden, MD, FACC, the roundtable brought together a diverse group of stakeholders representing government agencies, health systems, patients and industry to identify possible innovative policy solutions to improve patient-centered health outcomes.

As part of the event, David Blumenthal, MD, MPP, president of the Commonwealth Fund and former National Coordinator for Health Information Technology, provided personal insights into the development of the HITECH Act of 2009, as well as systemic factors affecting fluidity of digital data in research and potential paths forward. Additionally interactive discussions focused on how to address the challenges posed by data privacy and ownership, interoperability and U.S. Food and Drug Administration (FDA) regulation of digital health and other such laws and regulations. Among the questions considered:

  • Is the Health Insurance Portability and Accountability Act (HIPAA) compatible with today's technology?
  • How do we enable truly informed consent without significant costs or administrative burdens?
  • In terms of interoperability, should our focus be on the standardization of terminology and definitions?
  • How does the FDA allow for innovation?

Outcomes from the Roundtable – intended as a follow-up to the ACC's 2016 Innovation Summit and the 2017 Innovation Roadmap published in the Journal of the American College of Cardiology – will be used to inform that ACC's Advocacy efforts in these specific areas going forward.

Keywords: Health Insurance Portability and Accountability Act, Privacy, Ownership, American Recovery and Reinvestment Act, United States Food and Drug Administration, Follow-Up Studies, Informed Consent, Medical Informatics, Research, Government, Financial Management, ACC Advocacy

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