He began his talk by saying that for most of the last century, medical practitioners “generally treated the individual as a collection of symptoms, rather than treating the patient as an individual.” Patient-centricity has long been a goal of those seeking to reform healthcare on a number of levels – from improving the quality of care and reducing medical error to delivering care that is specific for each patient, rather than taking a disease-centric approach. By their very nature, digital health tools are themselves so focused on the particular patient that they are key to making that transition to a very different way of practicing medicine in the 21st Century.
Today digital health is often a picture of two extremes. Either we have our hand on the elephant and can describe that spot very well, but fail to see the entire picture. We may take our blood pressure using a device that is connected to our phone and sends the results to our doctor, for example. Or the opposite occurs and the entire picture is described in such a way that it sounds like a lot more like hope than reality – offering the world of tomorrow, but today. In his remarks, Dr. Gottlieb managed to straddle these extremes and evoke a very comprehensive picture of where we are, where we are going, and what FDA is doing to get us there.
FDA has recently approved several new innovations that are representative of the way that digital health is producing a new approach to diagnosis and treatment, and he cited the fact that FDA had authorized 51 new digital health products in 2017. For example, last year FDA approved a drug for schizophrenia in which an embedded sensor would allow for the sharing of information with the patient’s provider through a medical app. And this year, FDA approved what he termed “a type of clinical decision support software” using artificial intelligence in the diagnosis of stroke. Also this year, FDA approved a medical device combining AI with a special camera to detect diabetic retinopathy in diabetics in the primary care setting. In short, digital health is migrating from outside the physican’s office to inside. The ability of digital health to detect and to impact both the timing and depth of the information flow greatly enhance a growing role for individuality in approaches to treatment.
To facilitate that he said that the agency with oversight of this space must become as nimble as the technology that is being regulated. And to that end, he outlined four primary undertakings by the agency:
- Expanding the pre-market review of digital health tools as medical devices through the pre-cert program, providing the roadmap to the development of the Pre-Cert 1.0 which he stated will be ready by the end of 2018 and refined in the following year;
- Implementing a new approach to the review of artificial intelligence – applying the pre-cert program to AI in a way that will allow manufacturers to make device changes without re-submission and he foresees a time when AI can be incorporated directly into smart phones or wearable devices;
- Integration of digital tools to the work FDA is doing itself with the use of a new premarket digital safety program that will employ a digital submission process that will facilitate safety reports and data sets that are more readily analyzed, and
- Development of a new digital health incubator at FDA – called INFORMED with a focus to advance analytics in oncology.
There is more to the speech. He stated that FDA will be opening a public docket to get input on how to apply digital health to the drug development process. In his remarks he sent a clear message not only about the scope and pace of change that digital health brings to medical care, but also with respect to the agency that regulates it.