The Food and Drug Administration should not regulate healthcare IT the way it does traditional medical devices. However, some technology — for instance, that which monitors patient condition and makes medical decisions, such as reducing the delivery of analgesics — should be subject to regulation, and a system of post-market surveillance needs to be developed.
The recommendations were delivered to the Health Information Technology Policy Committee last week by a workgroup of physicians, vendors and tech experts. Chaired by Dr. David W. Bates, a professor at Harvard Medical School, the workgroup spent three months examining the circumstances and use of technology in medical settings, concluding that in most cases the FDA should not subject technology to the same pre-deployment regulation as medical devices.
The committee, established by the FDA to advise it on developing a “proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication” ass required by the Safety and Innovation
Act (FDASIA) of 2012.
In a presentation about its report, the workgroup observed that “HIT clearly appears to improve safety overall,” “However, literature also provides multiple anecdotes that
health IT creates new safety risks.”
Detailing its recommendations, the workgroup said healthcare IT should not be subject to FDA pre-market requirements except:
- Medical device accessories (to be defined clearly by FDA);
- Certain forms of high risk clinical decision support, such as Computer Aided Diagnostics (to be defined clearly by FDA);
- Software used in higher risk cases, including those where the intended use elevates aggregate risk.
In addition, the workgroup proposed that vendors “should be required to list products which are considered to represent at least some risk if a non-burdensome approach can be identified to doing so.”
Finally, the committee suggested the creation of a system of tracking — surveillance, the workgroup called it — of HIT. Said the workgroup:
Better post-market surveillance of HIT is needed
- Should include user self-reporting and reporting from vendors and transparency.
- Also post-implementation testing to ensure key safety-related decision support is in place.