The first patenting from Hemeo BV describes its development of Vantage, an artificial intelligence powered clinical decision support software for coagulation management.
Imaging is the number one way physicians track cancer progression and burdens within neurology and cardiology, but the ability to take imaging information and interact with it to make better decisions is becoming ever more complicated.
While the U.S. FDA’s final rule for regulation of lab-developed tests (LDTs) has yet to emerge, there is some reason to expect the rule will be met with litigation from clinical lab associations. The FDA’s Jeff Shuren said in remarks to this year’s meeting of the Medical Device Manufacturers Association that there is a legitimate problem with the accuracy of many LDTs, adding that while stakeholders are at liberty to question the FDA’s rulemaking, the agency’s experience in this area indicates that the question of LDT reliability is not up for debate.
The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.
The U.S. FDA’s recent final guidance for clinical decision support (CDS) software has drawn a second citizen’s petition for withdrawal, this time from a law professor at the University of Florida (UF). Barbara Evans of the UF School of Law asserted that the CDS final “raises constitutional issues” that are of sufficient importance to warrant an investigation led by the FDA commissioner’s office because of what she argues is a disregard for the First Amendment encoded in the guidance.
The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.
Developers of clinical decision support (CDS) software have their hands full with a recent U.S. FDA final guidance on these products, but the picture promises to become more byzantine with the publication of a draft rule by the Office of the National Coordinator (ONC). The new ONC proposal would require a demonstration of transparency for decision support intervention (DSI) predictive functions in order for that software to qualify for ONC certification, a requirement that might not overlap neatly with the FDA’s own transparency requirements.
The U.S. FDA raised some hackles with its final guidance for clinical decision support (CDS) software, thanks to provisions that some stakeholders argued flew against congressional intent regarding the regulatory status of some device functions. That final guidance is now the target of a petition by the CDS Coalition to withdraw and rewrite the final guidance, arguing that the agency is “doing an end run” around the limitations established by Congress regarding the FDA’s oversight of software as a medical device (SaMD).
The U.S. FDA managed to wrap up a guidance for clinical decision support (CDS) products after several years, one of several projects the agency was liable for in the area of digital health. While a much-needed draft guidance for change control for artificial intelligence algorithms made the guidance agenda for the FDA’s new fiscal year, that draft is only a B draft guidance priority, suggesting that a final guidance might not emerge until calendar year 2024, possibly later.
The U.S. FDA’s finalized guidance for clinical decision support (CDS) software was not an entirely isolated policy change inasmuch as there were several other guidances that were edited and reissued two days after the CDS final was published. One of these is the guidance for device software functions and mobile medical apps, which now encodes a transparency requirement as seen in the CDS guidance, a change that may represent a hazard for the unwary medical software developer.
