Marsha K. Millonig
Marsha K. Millonig B.Pharm., M.B.A.

THE FDA (FOOD AND DRUG ADMINISTRATION) news across a variety of its divisions regularly arrives in my email, and I enjoy the updates I have signed up for from the agency. Like me, you may be reading frequent FDA COVID-19 updates related to shortages, vaccines, personal protective equipment, and guidance. But a recent update captured my attention, with the agency announcing the formation of a Digital Health Center of Excellence in late September.

The goal of the Digital Health Center is to “Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.” FDA defines the broad scope of digital health as “categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine.” The new Digital Health Center will serve as the hub for a variety of initiatives the FDA has already undertaken to help smooth the pathway for digital health approvals, and it should help stakeholders by bringing information together in a central location. Specific objectives related to the new center’s goals are to:

  • Connect and build partnerships to accelerate digital health advancements.
  • Share knowledge to increase awareness and understanding, drive synergy, and advance best practices.
  • Innovate regulatory approaches to provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products.

The Digital Health Center will be housed within the Center for Devices and Radiological Health (CDRH) and be led by Bakul Patel, who was formerly the director of digital health at the CDRH. Digital health was already a hot trend, but with COVID-19, digital health and telehealth have taken on even greater importance. Remember when Fitbit and the Apple watch were launched? They were viewed as real innovations to help patients with their health. These devices have become ubiquitous. Be honest, do you have a wearable device on as you read this? I do. I think it’s my fifth or sixth device, and I’ve migrated away from a traditional watch as I glean each day how active I have been. But digital health is much, much broader than personal wearable watches.

Find Details on The Digital Health Market

A FEW EXAMPLES

Last June, the FDA approved the FreeStyle Libre 14-day continuous, wearable glucose device. It has become very popular among patients in the pharmacies where I practice, and allows patient to forego several-times-a-day blood glucose testing and finger sticks. Colleagues and friends have recently had pacemakers implanted and find they are remotely monitored 24/7, often across the country from where they live. Another colleague in the respiratory space has worked with the FDA for a number of years to develop digital data from the use of inhalers to help patients and their healthcare providers monitor chronic conditions like asthma and chronic obstructive pulmonary disease. Stop and think for a moment — what other digital health applications and The digital health market is expected to grow to nearly $640 billion in 2026, more than six times its size in 2019, and have an expected cumulative annual growth rate of 28.5% from 2020 to 2026 (see link at right). Digital health is no longer in its infancy but is becoming part of mainstream healthcare, and new solutions and coordination are needed to realize its full potential.

This thought was reflected by FDA Commissioner Dr. Stephen M. Hahn in a statement reported in MobiHealthNews that coincided with the Digital Health Center’s announcement: “Today’s announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings.”

For pharmacy system providers, it may be time to think about how to incorporate digital technology feeds into patient profiles so that pharmacists can use this data in their clinical decision-making. What interfaces would be required to populate device data into a patient’s medical record? Additionally, as providers no doubt you have been thinking about how to adapt systems to provide telehealth during this pandemic. All these activities will benefit from the new Digital Health Center.

As digital health continues its evolution, securing devices at home and work, securing internet-connected devices in healthcare, and securing other technological innovations will all need to be addressed. October was National Cybersecurity Awareness Month. As part of its digital health security efforts, the FDA created a new discussion paper, entitled, “Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework.” The paper was developed to provide best practices to consider when communicating with patients and caregivers about cybersecurity vulnerabilities. The agency is welcoming comments on the paper, which can be downloaded at here. I encourage you to review it and consider any actions you may need to take to make your systems more digital health friendly and secure.

You can keep up on digital health initiatives at the Digital Health Center website, which outlines its phased evolution, and through push email FDA news. Or sign up for the center’s updates. I have also found MobiHealthNews, a complimentary daily e-newsletter from the Healthcare Information and Management Systems Society (HIMSS) to be a good source for following digital health trends. CT

Marsha K. Millonig, B.Pharm., M.B.A., is president and CEO of Catalyst Enterprises, LLC, and an associate fellow at the University of Minnesota College of Pharmacy Center for Leading Healthcare Change. The author can be reached at mmillonig@catalystenterprises.net.

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