FDA Turns to AI and Digital Health, So Why Are There Still Fax Machines?


The agency recently said that it plans to be more proactive in this space, what the health care industry has been slow to adapt.

Recently, FDA Commissioner Dr. Scott Gottlieb, spoke discussed how he sees digital health playing out and where the agency stands in a speech titled "Transforming FDA's Approach to Digital Health." Some things he said are worth exploring in more depth.

Gottlieb started out by saying that the digital health space has really matured and is the time for regulation.

"Digital health tools have vast potential improve our ability to accurately diagnose and treat disease and to enhance the delivery of health care for the individual, making medical care truly patient centric -- empowering the individual," Gottlieb said.

Yes, we are entering the era of digital therapeutics (DTx) and may get to the point where digital health tools are integrated into or prescribed for into patient care.

"In addition to empowering patients, digital tools are giving providers a truly holistic view of patient health and function through new data flows. These tools are helping redesign physician workflow to better coordinate patient care," Gottlieb said.

"The trend towards connectivity and seamless monitoring is reflected in the 51 digital health products authorized by the FDA in 2017," he said "One of those included a sensor embedded in a drug for schizophrenia that can allow patients to share treatment data with their physician through a medical app."

Gottlieb was referring to Abilify MYCITE, which can track oral ingestion of adherence for patients. MYCITE will not be the first or last of these technologies, and it stands to reason that pharmacists will be dispensing new drug technology we never heard about in school.

Technology continues to change the medical field, and the FDA needs to play a significant role.

Gottlieb highlighted that fact when he said that the "... FDA plays a critical role in supporting this continued innovation as part of our mission to protect and promote public health. First and foremost, we must make sure that our approach to regulating these technologies maintains our scientific gold standard for product safety. We must always put protecting patients at the forefront of what we do. As part of our mission, we must also take steps to make sure that beneficial new technologies can efficiently advance and be made available to patients in a timely way. This is ultimately how patients are going to benefit from science."

What is striking is how technology and novel therapies are using DTx get integrated into care. For instance, just the interpretation of the medical literature becomes a curious thought. For so long, the concept of evidence-based medicine in pharmacy education focused on the use of randomized controlled trials and related studies to judge the appropriate use of medications in patient care. If DTx enters the picture alongside that of medical treatments, do we need to consider that the 2 are tied together? For instance, suppose there was an intervention tested that used drug X alongside platform Y, which provided adherence support. If drug X does show positive results compared with the control, does that mean that drug X needs always to be partnered with platform Y to work? It will be interesting to see what the FDA will say about this as we continue down the path of higher use of DTx.

This all leads to a new initiative from the FDA: its Digital Health Action Plan, which will help work with developers to incubate ideas and companies. The FDA has new regulatory approaches that will help companies understand what they need to do to meet compliance for their products. This, in turn, leads to the FDA's Pre-Cert Program.

As part of this initiative, the FDA will consider how to apply digital health to drugs, especially related to drug developments. For years, the pharmaceuticals industry has struggled with how to implement digital health into its pipeline, so this is a useful development. Take, for instance, new trials integrating mobile applications into Parkinson's disease that can help measure the impact of therapy on symptoms and disease modulation. Other areas that can be disrupted include the post-market surveillance requirements, and this can help aid companies to monitor other issues. The FDA also announced its interest in the use of artificial intelligence (AI) in health care. AI can apply to many topics in health care, but the issue has been, under what jurisdiction. Can we, for instance, rely on AI to predict the risk of cancer? Or perhaps, closer to home, could AI be used in the medication verification process?

These new initiatives from the FDA are intriguing, but we must keep in mind that the health care field has been slow to adapt to technology. The rollout of electronic health records platforms to hospitals are an example of the problems faced with just moving to an electronic database. Considering the rise of AI, DTx, and other technological innovations, these companies may move faster than the medical field. Will the new FDA initiatives help make this a more natural process, or will it befuddle the market even more?

Pharmacy is ripe for disruption. We still use fax machines every day, and pagers are still a "thing" in some institutions. Many of our pharmacy management systems could stand an upgrade, but how do we integrate this technology in a way that makes our workflow better? AI technology and machine learning could help the profession better predict adverse effects, drug interactions, and nonadherence. And yet, some of us dread the idea that others outside the pharmacy field could start dictating how we should work, without any insight into our operations. Perhaps when tech companies come knocking, we need to keep our wits about us.


FDA. Transforming FDA's approach to digital health. fda.gov/NewsEvents/Speeches/ucm605697.htm. Updated April 26, 2018. Accessed May 10, 2018.

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