The Healthcare Information and Management Systems Society (HIMSS) has written a letter to Health and Human Services Secretary Kathleen Sebelius offering feedback on health IT regulation, pertaining to the Food and Drug Administration Safety and Innovation Act (FDASIA) 2012.
The letter starts off with a clarification that health IT products used primarily for the subsequent transmission, storage or management of data, including electronic health records (EHRs) and Clinical Decision Support (CDS) systems, do not fit the "definition of, nor would be appropriately regulated as, medical devices."
As such, HIMSS writes, these (health IT) products should "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."
HIMSS says this oversight framework should act in concert with medical device regulation framework from the standpoint of the end-user or manufacturer.
"We recognize that health IT and medical devices are interwoven into a single, broad patient care ecosystem, and believe that the new health IT framework can complement the existing medical device regulatory process. Our comments offer proposed elements and rationales of such an oversight framework," HIMSS writes.
In the letter, signed by Chair of the HIMSS Board of Directors Scott MacLean and President & CEO Steve Lieber, the advocacy group mentions four areas this framework should address. This includes:
- Balancing the costs and benefits of any program proposal;
- Ensuring clear, consistent and non-duplicative language and enforcement;
- Being affordable to those expected to bear direct and indirect compliance costs; and
- Avoiding adding burdens that inhibit or delay improvements to systems that improve care delivery and safety.