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FDASIA Comments; Open Outcomes Based Regulation

The U.S. government and health care industry are engaged in a complex set of conversations, proposals and negotiations about the regulation of connected health tools, including software, devices and cloud services.  The 113th Congress and relevant agencies are involved, including FDA, FCC and the Office of the National Coordinator for Health IT (ONC), as are health IT, medical device, telecommunications and consumer sectors.  Substantive debate issues include:
  • When is software, including applications and decision support platforms, going to be regulated as a medical device?
  • Where is the dividing line between the diagnosis and treatment of disease, which is subject to regulation by FDA, and wellness products, which are exempt?
  • When a non-medical device is used in conjunction with a medical device (including regulated software, etc.), when does this device become subject to regulation by the FDA as an accessory?
  • How should clinical decision support software (e.g. “Dr. Watson”) be regulated, if at all?
One of the most important focal points for these conversations surrounds the recommendations of the FDASIA Health IT Report by the FDA, FCC and ONC.  The comment period closed recently with 172 comments being filed.
WLSA’s comments on the report are designed to resolve the key issues by providing an alternative approach to managing safety and efficacy, and we are joined in our comments by CTIA.  This approach is de-regulatory and unlike the current system it can address the two fundamental defects in current regulatory systems:
  • First, the pace of regulation and innovation are inescapably mismatched.  Regulation is cautious and slow.  Innovation is aggressive and fast.  Moreover, regulatory gates tend to become barriers to both competition and innovation.  As a result, medical products do not become “better and cheaper” over time as do other products such as automobiles and consumer electronics.
  • Second, the status quo for both personal health and public health are unsatisfactory and getting worse, so it may be more harmful to keep promising solutions out of the market than to introduce them, assuming it is possible to monitor their outcomes in the real world.  The tools of connected health offer this monitoring capability.
With this background, please review our proposal, linked here.  Please share any thoughts in the comments section.
FDASIA Comments; Open Outcomes Based Regulation