Digital health technology has revolutionized the healthcare field, affording new patient care techniques and increased patient control. The FDA’s new Digital Health Center of Excellence establishes digital health as one of the agency’s central focuses and provides helpful resources for medical device manufacturers working in the field.
The Digital Health Center of Excellence (DHCE)
On September 22nd, the U.S. Food and Drug Association launched its new Digital Health Center of Excellence (DHCE), designed to further the agency’s dedication to advancing digital health technology. The center will focus primarily on mobile health devices (mHealth), Software as a Medical Device (SaMD), wearable technology, and health information technology (IT). Telehealth and telemedicine also fall under the DHCE’s guidance.(1)
Working within the Center for Devices and Radiological Health, the DHCE hopes to advance digital health practices and technology, modernize digital health policy, and spearhead the agency’s digital health initiatives. The program will also provide centralized expertise and resources regarding digital health technology and legislation, making this information available to manufacturers, FDA staff, and the public.(2)
According to FDA Commissioner Dr. Stephen M. Hahn:
“[This] 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.”(3)
Bakul Patel – a leader of the agency’s digital health efforts since 2010 – will serve as the DHCE’s inaugural director. Patel previously directed the Center for Devices and Radiological Heath’s digital health division, where he helped develop a software precertification pilot program, allowing companies with tested quality assurance protocols to update their digital health technology quickly and efficiently.(4)
Why Do We Need a Digital Health Center?
The establishment of a digital health center coincides with a continuous expansion of the digital health industry.5 Statistics indicate that healthcare providers increasingly rely on networked medical devices and other mobile health technologies to provide patient care, while patients themselves often track health data through apps or wearable devices.(6)
- In 2017, 87% of Americans used at least one digital health tool.(7)
- In 2019, 69% of the US population either owned a wearable device or planned to buy one in the next year.(8)
- In 2019, 66% of Americans were willing to use telehealth, and 30% of doctors adopted the technology.(9)(10)
Amongst this increase in the pervasiveness of digital health technology, the Digital Health Center of Excellence ensures new devices are safe for the public. It can also provide resources for medical device manufacturers who hope to enter the digital health industry or have been pushed to do so by changes in economic demands.
Digital health has also proven a helpful tool during the Covid-19 pandemic, allowing healthcare providers to respond to cases more effectively.11 The DHCE, in addition to ensuring the safety of new technology, can provide resources for manufacturers hoping to create devices which treat or manage the disease.
How Do DHCE Goals Help Medical Device Manufacturers?
According to the FDA, the DHCE has four main goals:
- Empowering Stakeholders
- Connecting Stakeholders
- Sharing Knowledge
- Innovating Regulatory Approaches
Each goal has a direct positive impact on medical device manufacturers, from the formation of external partnerships to the implementation of digital health training.
The Digital Health Center of Excellence empowers device manufacturers to improve their products through responsible and high-quality innovation. To do so, the DHCE:
- Sets and leads strategic direction in digital health technology;
- Launches initiatives that advance digital health technology;
- Exercises a new capacity to oversee and leverage digital health technologies; and
- Provides scientific expertise and policy advice.(12)
By improving scientific evidence related to digital health technology, the DHCE allows device manufacturers to improve the quality and safety of their devices. The center also publishes helpful guidance documents on topics like medical device cybersecurity and post-market surveillance, which recommend effective practices for manufacturers both before and after their products reach the market.(13)(14)
The Digital Health Center of Excellence facilitates partnerships by:
- Fostering collaboration in common interest areas;
- Communicating the FDA’s research interests;
- Advancing international standards of digital health technology; and
- Providing access to internal and external digital health experts.15
The center hopes to accelerate advancements in digital health technology by creating a collaborative development process. These steps allow manufacturers with similar interests to work jointly, combining resources to reach common research objectives. Groups like the Network of Digital Health Experts, Xavier Artificial Intelligence World Team’s Collaborative Community, and the Ophthalmic Imaging Collaborative Community a just a few examples of organizations which leverage collective opportunities to reimagine digital health.(16)(17)(18)
The DHCE prioritizes granting widespread access to highly specialized knowledge by:
- Sharing information related to advancements in digital health;
- Establishing and promoting effective digital health practices;
- Creating and disseminating shared resources; and
- Offering training opportunities related to digital health innovation and policy.(19)
By increasing awareness of digital health trends, the center helps device manufacturers find recent and relevant information on the kinds of products they produce. Training programs and online databases facilitate the spread of this information to relevant manufacturing bodies, without requiring extensive involvement with the FDA.
Innovating Regulatory Approaches
The Digital Health Center of Excellence works to establish and apply useful digital health regulation practices by:
- Developing effective medical device regulatory approached which meet FDA standards without becoming burdensome;
- Provide clarity on regulations through increased accessibility; and
- Ensure transparent and predictable product reviews.(20)
Standardizing an effective approach to device regulation allows manufacturers to design clinical trials and development procedures which ensure the best chance of FDA clearance. By balancing efficacy with clearly defined expectations, programs like the Software Precertification Program allow for a faster development of digital health technology, without jeopardizing patient safety.(21)
Digital health software is a fixture of the modern American healthcare system, allowing patients to take control of their own health and healthcare providers to improve the effectiveness of their care. The Digital Health Center of Excellence will continue the advancement of digital health technology, while simultaneous helping device manufacturers create better, safer products.
- FDA Launches the Digital Health Center of Excellence. (2020, September 22). Retrieved from https://www.fda.gov/news-events/press-announcements/fda-launches-digital-health-center-excellence
- Hale, C. (2020, September 23). FDA launches digital health-focused center of excellence. Retrieved from https://www.fiercebiotech.com/medtech/fda-launches-digital-health-focused-center-excellence
- Digital Healthcare Market Research Report – Global Forecast till 2025 Global Digital Healthcare Market: Information by Technology (Digital Health Systems, Telehealthcare, mHealth, and Healthcare Analytics), by Application (Cardiology, Diabetes, Neurology, Sleep Apnea, Oncology, and others), By Delivery Mode (On-Premise and Cloud-Based), by Components (Software, Services, and Hardware), By End User (Healthcare Providers, Healthcare Payers, Pharmaceutical Companies and others) and by Region (Americas, Europe, Asia-Pacific, and the Middle East & Africa) – Forecast till 2025 (Rep. No. MRFR/HC/6167-CR). (2019). Market Research Future. Retrieved from https://www.marketresearchfuture.com/reports/digital-healthcare-market-7636
- “Connected Medical Devices Security Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2017-2025.” Retrieved from https://www.transparencymarketresearch.com/connected-medical-devices-security-market.html
- Zweig, M., Shen, J., & Jug, L. (2018). Healthcare consumers in a digital transition. Retrieved from https://rockhealth.com/reports/healthcare-consumers-in-a-digital-transition/
- Clark, E. (2019, November 14). 3 Ways Google Can Compete With Apple in the Wearables Market. Retrieved from https://themanifest.com/app-development/3-ways-google-compete-apple-wearables-market
- Telehealth Index: 2019 Customer Survey (Rep.). (2019). Retrieved https://static.americanwell.com/app/uploads/2019/07/American-Well-Telehealth-Index-2019-Consumer-Survey-eBook2.pdf
- O’Reilly, K. B. (2020, February 06). Why physicians’ use of digital health is on the rise. Retrieved from https://www.ama-assn.org/practice-management/digital/why-physicians-use-digital-health-rise#:~:text=O’Reilly&text=What’s%20the%20news%3A%20Physician%20use,AMA%20survey%20of%201%2C300%20physicians
- Whitelaw, S., Mamas, M. A., Topol, E., & Van Spall, H. G. (2020). Applications of digital technology in COVID-19 pandemic planning and response. Viewpoint, 2(8). https://doi.org/10.1016/S2589-7500(20)30142-4
- Center for Devices and Radiological Health. (n.d.). Digital Health Center of Excellence. Retrieved September, 2020, from https://www.fda.gov/medical-devices/digital-health-center-excellence
- Cybersecurity. (n.d.). Retrieved from https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity
- Aggregating Multiple Real-World Data Sources Using a Patient-Centered Health Data Sharing Platform. (2020, May 26). Retrieved from https://nestcc.org/aggregating-multiple-real-world-data-sources-using-a-patient-centered-health-data-sharing-platform/
- Center for Devices and Radiological Health.
- Network of Digital Health Experts. (2020, September 22). Retrieved from https://www.fda.gov/medical-devices/digital-health-center-excellence
- AI World Team. (n.d.). Retrieved from https://www.xavierhealth.org/ai-world-team
- CCOI. (n.d.). Retrieved from https://www.cc-oi.org/
- Center for Devices and Radiological Health.
- Digital Health Software Precertification (Pre-Cert) Program. (2020). Retrieved from https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program