New FDA Final Guidance May Pump the Brakes on Software Designed to Assist and Improve Doctor’s Clinical Decision Making
Medicine continues to transition into a new era, augmented by big data, machine learning, and artificial intelligence.[1] Software processing of large data sets is expected to play a significant role across the ever-growing healthcare industry, from predicting heart attacks to assisting patient mobility to clinical trials.[2] One particularly exciting area involves software designed to support clinical decision making, which may reduce unnecessary healthcare utilization, enhance compliance with clinical guidelines, and cut costs.[3] Yet recent guidance by the U.S. Food and Drug Administration (“FDA”) threatens to upend the rapidly developing area of healthcare innovation.[4]
Released in September 2022, the final guidance diverges significantly from the draft that the agency released in 2019 and suggests that far more software applications could be subject to increased regulatory scrutiny.[5] Ostensibly, the guidance was intended to clarify open questions regarding the types of clinical decision support (CDS) software solutions that the agency deems too risky for regulatory exemption. Per the 21st Century Cures Act, which amended Section 520 of the Federal Food, Drug & Cosmetic Act, certain medical software functions, including CDS software, were meant to be excluded from the definition of “medical devices.”[6]
In particular, the released guidance omitted full sections on the International Medical Device Regulators Forum’s (“IMDRF”) risk categorization, which would have likely reduced enforcement for software functions deemed to be of lower risk by the IMDRF standards.[7] The guidance also narrowed the agency’s interpretation of two clinical decision support software criteria from the statutory exemption for software in the definition of a medical device.[8] This means that the FDA will take a more expansive view of what types of software qualify as medical devices, likely subjecting CDS software to increased regulatory scrutiny.
Industry groups are not happy with the agency’s reversal on the long-awaited guidance.[9] In December 2022, the Health Information and Management Systems Society (HIMSS) Electronic Health Record (“EHR”) Association sent a letter to the FDA expressing concerns about the guidance.[10] The group notes that the guidance does not reflect the reality of CDS technology, which is often configured by provider organizations after release by the developer.[11] Further, the guidance could disrupt the availability of many CDS solutions that have been deployed for over a decade, in compliance with previous EHR certification requirements, negatively impacting physicians and patients.[12] Ultimately, the EHR groups are concerned that increased regulation will greatly inhibit the very purpose of the CDS software—to synthesize troves of patient data with evidence-based standards of care to assist physicians in clinical decision making for diagnosis and treatment plans.[13]
The FDA has yet to formally respond to the industry’s objections. It’s possible the agency may amend or even rescind its guidance in light of the apparent issues the guidance creates. However, the FDA could also hold fast on its path towards enhanced regulatory enforcement in the CDS space. If it does, the agency risks a significant scaling back in the clinical recommendation capacity of CDS technology, stifling the industry before it could truly get off the ground and realize its promise.
Footnotes
