Pharma R&D Today
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A New Innovative Approach: Application of Digital Healthcare
Posted on August 4th, 2017 by Dr. Makarand Jawadekar, Ph.D in Pharma R&D
Just last week, US FDA Commissioner Dr. Scott Gottlieb published a blog on the FDA web site that talks about new policies the FDA is going to be acting upon. These new policies are designed to empower the consumer to act on his own and allow ‘digital healthcare’ technologies to help promote better health. This will also help pharma and biotech companies achieve innovation at a faster rate, where certain technologies would selectively help a patient choose a right approach to help themselves through diagnostic tools and other technologically innovative approaches. The FDA’s initiative will include a novel approach, which will be adapted for a post-marketing stage.
There are thousands of health care-related apps for smartphones, and there would be a tremendous usage of these apps by patients and consumers. These apps would help them keep track of their medicines, frequency, their vital signs and their fitness-related stats. These apps would also allow efficient clinical practice and decision-making for diagnoses of patient conditions, and they would enable physicians to track progress in real time. In the public health arena, these apps would also have applications in tracking the opioid epidemic.
The FDA wants to partner with many of these tools, which are innovative in nature and can bring more discipline to the patient-physician relationship (while also helping families who handle care for patients). Congress is advancing these goals with the 21st Century Cures Act, which in turn ultimately helps public health initiatives. The FDA is adapting the approach as a risk-based regulatory framework for overseeing medical technologies and innovation in such digital health-related products.
In post-marketing/ phase IV studies, I think these tools would be of tremendous use, enabling the collection of real world data gathered through different national agencies. Pharma and biotech companies would certainly approve of these new initiatives, which will be partnered through the FDA and parallel regulatory bodies to monitor serious adverse events throughout the life cycle of a new product on the market. Long-term effects of certain medications would provide value to others who are looking to change or modify their therapies. It is always good to have the ‘big data analytics’ done continuously on such public health-related exercises. The data output would be administered through some external organizations, which would have some kind of strategic alliance with the FDA. Also, healthcare data-based companies such as WellTok or Predilytics would bring further value by taking the FDA’s initiative to the next level, helping the general public, consumers, and patients in return. I applaud the efforts of Dr. Gottileb to have these new initiatives nurtured and taken forward with some new goals and mission.
They are also conducting a pilot through CDRH (Center for Devices & Radiological Health) to provide new approaches to digital health technology as well as the 21st Century Cures Act. It’s a voluntary pilot program, and, according to Dr. Gottlieb, the program would enable the agency to develop a tailored approach. This pilot will help establish appropriate criteria for standing up a pre-certification program. The software product should meet the definition of a medical device, and the company needs to have the tracking through key performance indicators (KPI). The FDA is launching this Digital Health Innovation Action Plan. This initiative is meant to help patients better manage their chronic disease (which will ultimately result in fewer visits to doctors and hospitals) and have more preventative measures achieved through novel digital technologies and innovations at our disposal.
I applaud these wonderful efforts by our new FDA commissioner. We look forward to getting further guidance from the FDA. I am sure the rest of the world would follow these initiatives as well as we move forward!
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All opinions shared in this post are the author’s own.
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Dr. Makarand Jawadekar, Ph.D
Independent Pharma Professional
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