Submit Your Comments on the Future Regulation of Health IT

Calling All VCs, Entrepreneurs, Developers, and HIT devotees: Submit Public Comments on the Future Regulation of Health IT.

As health IT has evolved to address the challenges and opportunities in healthcare delivery, questions about patient safety, risk, and quality of technology have likewise emerged.  So too, the ability of innovation in health IT to improve healthcare and the patient experience has been highlighted.

In order to balance those concerns with the continued promotion of innovation while avoiding regulatory confusion, Congress passed legislation that charged the Food and Drug Administration (FDA) to conduct an 18-month study in partnership with the Federal Communications Commission (FCC) and Office of the National Coordinator for Health IT (ONC) to develop a risk-based regulatory framework for health IT.

As a result of that legislation, the FDA Safety and Innovation Act or FDASIA (pronounced “Fah-Day-Jah”), the three agencies convened a workgroup within the HIT Policy Committee to gain feedback from diverse stakeholders in the industry. The nearly 30 members represent EHR and mobile app developers, academic researchers, venture capitalists, health systems, legal and FDA experts, and providers and patients.  The workgroup has established three subgroups—Taxonomy, Innovation and Risk Assessment, and Regulations—and will produce recommendations to advise the agencies’ report by August 2013.

To augment the feedback provided by the workgroup, a request for public comment (RFC) has been published to the Federal Register by the agencies.  While the RFC will remain on the Federal Register until August 31, 2013, comments submitted by June 30, 2013 will be taken into account by the workgroup and are highly encouraged.  You can join upcoming meetings of the FDASIA workgroup by going here and you can submit comments online at http://www.regulations.gov.

For first-time commenters, here are a few pointers:

• Address the document to the ONC (Attn: Steve Posnack) and reference the title of the rule
• Identify yourself /your organization, who/what you are and any relevant interests you represent (e.g. “we provide technology to doctors”), and why you are commenting (e.g. “experience developing x” or “experience with y regulatory process”)
• Comments are public, so make sure you are comfortable with the content being widely available
• You can respond to the specific questions posed in the RFC and/or provide additional feedback structured as you choose
• Highlight ideas that you support as well as ideas that you oppose
• Provide as many specific examples, real world insights, or data points as you can to support your opinions
• Include details that the government may have little to no insight into:
  • Your processes, your challenges and opportunities, your experiences with government and understanding the regulatory process,
  • The impact of regulation or lack thereof,
  • How you think about developing/investing/policy-making,
  • What innovation means to you and how to promote it, what risk means to you and how you mitigate it
  • How you interact with providers and consumers, feedback you’ve received from them
  • New ideas for regulation, non-regulatory pathways

Your feedback is incredibly important to inform the future of health IT regulation!  Don’t be intimidated by the process and if you need help, you can always reach out to me @laurenfifield on Twitter or by commenting on this post.

 

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