Industry groups have raised several concerns about clinical decision support (CDS) guidances released by the Food and Drug Administration in December, including some that argue the FDA’s approach could harm patients and force software vendors to pull their products off the market.
The CDS Coalition, led by Bradley Merrill Thompson, a medical device attorney with Epstein Becker & Green in Washington, D.C., was particularly critical of the draft guidance that the industry had been waiting on for years. In comments submitted (PDF) to the FDA, the group said the guidance would “substantially expand the scope of FDA regulation” forcing many vendors to remove low-risk products that have been on the market for decades because it “does not simply do mundane calculations that users could do themselves.”
Ultimately, the FDA’s stringent regulation would hurt patients by discouraging useful software development. Failure to adopt a risk-based approach “violates federal law and policy” CDS Coalition wrote.
“Given that the guidance was seven years in the development process, we expected much more,” Thompson wrote in an email to FierceHealthcare. “FDA had been repeatedly promising to make the guidance risk-based, but then didn’t. We have no idea why. We certainly hope that FDA reconsiders its approach, and develops a new proposed guidance.”
CDS Coalition wasn’t the only group with concerns about overregulation and the increasing use of machine learning. Several other health IT associations weighed in with their own comments:
- Health IT Now: In comments (PDF) to the FDA, the group said the agency ran afoul of language in the 21st Century Cures Act that says software that allows a clinician to independently review recommendations should not be included as a medical device. The FDA’s guidance dictates that clinicians must be able to review the recommendations based on publicly-available information—a bar Congress did not intend to establish, the group argued.
- CHIME: The College of Healthcare Information Management Executives called for (PDF) more clarification regarding what software falls under FDA oversight, particularly whether the agency considers ICU dashboards and EHRs within their enforcement authority. The group argued that ICU dashboards should be excluded from oversight and that individual EHR functions that utilize CDS should be regulated rather than the whole platform.
- AMIA: The American Medical Informatics Association also raised concerns (PDF) about the clarity of the FDA’s guidance, while also noting that CDS software has been “developing at a tremendous rate.” As experts have pointed out, the “black box” of artificial intelligence and machine learning makes it difficult for clinicians to evaluate the clinical reasoning behind some recommendations. AMIA recommended the FDA host a public meeting to discuss standards for CDS transparency. “While we do not contend that such functionality should be free from FDA oversight, there is a need to explore the range and types of potential applications related to decision support software, and a need to discuss their varying risks of harm to patient safety and public health," the group wrote.
The FDA faces a difficult balancing act in shaping regulatory guidelines that the industry has been craving for several years. Although the 21st Century Cures Act exempts software that can be independently reviewed by physicians, the agency is also facing pressure to adopt a risk-based approach to CDS oversight that differentiates between software that can diagnose the common cold versus cancer.
On the other hand, many see the guidance as a first step that provides software developers with goal posts for regulatory oversight.