FDA’s Relaxed Software Regulations Opens Doors to The Digital Doctor
​​[Posted on: Thursday, December 14, 2017]

The recent movie, Passengers, showed a machine that could diagnose diseases, prescribe medications, and perform several complex medical procedures, all without the intervention of a human doctor. It seems real life may be catching up to science fiction sooner than we may think. Over the last year, FDA has slowly eliminated or toned down several medical device regulations applicable to medical software. The most recent rules, announced this week, practically open the door to software-based medical decisions which ultimately could lead to software-assisted medical care, or the Digital Doctor. FDA announced that it would no longer regulate Clinical Decision Support (CDS) software used by physicians to independently review their recommendations against those made by software regarding clinical diagnosis and treatment decisions. Medical decisions by physicians are mostly based on review of test results, imaging and physical exam. Specifically, a given physician bases his/her treatment recommendations on the review of data points whose meaning is well understood in clinical practice guidelines and published literature. Such tasks can be automated by a software algorithm which could make similar decisions based on the review of similar information and the same clinical guidelines. While the rule allows only that software be used for secondary recommendations and the doctor should still make the primary decision, from a practical point of view, it would be impossible for a doctor to not second-guess his/her recommendations, if the software gives a different decision than what the doctor came about. Overtime, doctors would increasingly depend on the software to guide them about medical decisions. Similarly, FDA will no longer regulate most Patient Decision Support (PDS) software, which does tasks very similar to those done by the CDS but at the patient level using terms that would understandable to patients. Such software-assisted decision systems could over time eliminate the need for human doctors for most common healthcare decisions. Two new and one final guidance documents, cement the current regulatory regime for software regulation by FDA. This development should be a welcome relief to software developers, who can go about making science fiction real without worrying much about the regulatory oversight. The guidance documents provide several examples that draw the fine lines between what will not be regulated and what would still require FDA approval but the overall tone of the document indicates strong support from FDA for most software used by patients and doctors alike. It seems we will be talking about Artificial Intelligence (AI) systems in medical care sooner than we all thought possible.