When the FDA handed down its final guidance on mobile medical apps it very intentionally left plenty of room for enforcement discretion.
And while that may have been a welcome stance in developer’s garages and basements, it certainly pushed a range of health technologies into something of a no-man’s land.
Take, for instance, those products used to manage, store and transmit data – such as EHRs and clinical decision support tools – which, “according to their current capabilities, neither fit the definition of, nor would be appropriately regulated as, medical devices,” according to a letter that HIMSS has sent to Health and Human Services Secretary Kathleen Sebelius.
The FDA’s interpretative dance, moving to calculate regulatory decisions based on whether a particular product fits the description of a medical device, did little to address the EHR or CDS categories.
Which is why HIMSS called for a new regulatory framework (PDF) in its letter.
“HIMSS recommends that such health IT products be subject to a new risk-based oversight framework that takes into account factors such as risk relative to intended use and cost/benefit of any proposed oversight and the construct of shared responsibilities, with the intent of ensuring patient safety and appropriate improvements in quality, effectiveness, and efficiency of care delivery,” the association wrote.
HIMSS explained that an effective framework would:
- balance costs and benefits,
- ensure clear, consistent, and non-duplicative language and enforcement,
- be affordable to parties expected to shoulder the costs, and
- avoid adding burdens that stall improvements to care delivery and safety.
“Health IT systems must be safe and facilitate optimal user workflow and usability. To that end, health IT often includes high levels of very beneficial, and user sought customization capabilities to providers. The benefits are many, allowing providers to tailor products to fit their specific needs and those of their patient populations,” the association wrote. “Therefore, it is essential that regulation and oversight recognize the importance of focusing on manufacturers' intended use for a product as opposed to the full range of possible customizations reflecting end users clinically informed judgment, with a focus on usability throughout.”
See also:
Bounty: $10 million for building Star Trek-like tricorder mobile medical scanner
