We have addressed the FDA Pre-Cert program for SaMD (Software as Medical Device) on several occasions. The basic premise of Pre-Cert is that reasonable assurance of low to moderate risk SaMD safety and effectiveness can be achieved by looking at the processes of the vendor/developer rather than looking primarily at the product itself.
The Office of the National Coordinator for Health Information Technology (ONC) is part of the Department of Health and Human Services. While Health IT might sound rather expansive, in the ONC context it means record keeping software that receives, sends, and stores health information. This is largely contained within the concept of the Electronic Health Record (EHR). One might think that an EHR also meets the definition of a medical device, but this notion was resolved by the 21st Century Cures Act of 2010 which expressly declared that software that is intended to serve as an electronic patient record is excluded from the FDA’s portfolio. Various policy issues for the FDA under Cures have been addressed in a Guidance on Changes to Existing Medical Software 1 1 2 Policies Resulting from Section 3060 of the 21 3 st Century Cures Act.
One remaining area of overlap is Clinical Decision Support (CDS) which are included in some EHRs and which may still be a medical device, depending in part on whether the user can see and duplicate how the CDS reached its conclusions. For systems based on machine learning duplicate presumably does not mean looking at the same extensive data set that was used to build the CDS.
Furthermore the Cures act exclusion of EHRs from medical devices has the express exception that an EHR cannot interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. Additional FDA guidance on CDS has been long awaited following the December 2017 Draft Guidance on the subject.
ONC exercises its authority over EHRs by having specific performance criteria against which products are measured as part of a certification process. The current criteria are known as the 2015 Edition, notwithstanding that it is now 2019. Thus, EHRs are required to have certain specific functionality and the certification process tests such functionality.
In a wide-ranging 724 page proposed rule released on February 11, 2019, ONC has proposed a number of changes to the 2015 Edition, some driven by express provisions of the Cures act. In addition, ONC has commented on FDA’s Pre-Cert pilot. ONC notes that Pre-Cert is being developed in order to create a tailored approach toward recognizing the unique characteristics of digital technology by looking first at the firm, and then at its products.
The idea that software is fundamentally different and cannot be regulated in traditional ways is a conceit of the software world. ONC suggests that it can piggyback on the pilot program such that a developer who is FDA pre-certified for SaMD, and who also has a Health IT product (as defined by ONC) could qualify for, and benefit from, further efficiencies under ONC’s certification program.
We might note here that this would give a presumed big advantage to developers who are in both the medical device and the EHR space. The degree of such an advantage depends on the final regulatory burden of pre-cert compared to more traditional regulation. Interestingly, ONC expressly recognizes that this might not be a good idea by noting that stakeholders may not agree that the FDA program sufficiently aligns with ONC’s program. Further, ONC says that this idea may eventually be determined to be infeasible or insufficient to meet their goals of reducing burden and promoting innovation.
An alternative idea floated is that ONC could create its own version of pre-cert rather than rely on FDA’s. Note here that reducing burden and promoting innovation are common agency buzzwords, because who could be against there two things? The burden component is often expressed as the assertion that the agency is committed to a “least burdensome” approach. On the other hand, I don’t think I have ever seen an agency assert that its goal is other than to be the least burdensome, making it a somewhat hollow phrase.
The proposed rule has a 60 day comment period following which ONC will eventually issue a final rule.