Imagine a platform where innovations meet modern healthcare services while following regulatory requirements. Such a platform is the Digital Health Center of Excellence (DHCoE) which is designed and governed by the FDA. Launched in September 2020, this platform is specifically designed to shape and coordinate Digital Health services with the FDA and is derived from the Center of Devices and Radiological Health (CDRH). The major target of the DHCoE is the rapid innovation, designing, development, and review of medical devices while integrating with start-of-the-art technologies.1
DHCoE will prove to be a critical tool when used by software (or system) engineers and medical device manufacturers to enhance their services and perform quick device market releases in service areas such as Cybersecurity, Regulatory Science Advancement, and Regulatory Innovation.2 Also, this platform embraces entities such as mobile or web-based applications in medical devices, Software as a Medical Device (SaMD), wearable health devices such as smartwatches, and the resources used for medical device studies. Integrating such elements with the latest technological resources, and with DHCoE as the governing entity, will offer novel regulatory methods including ways for harmonizing international standards and creating a panel of highly expertized professionals for improving existing or new medical devices. This facilitates faster access to Digital Health and knowledge sharing events among all users and platforms. Examples include the proposed discussion paper for SAMDs which are built using AI/ML and Cybersecurity in medical devices.3
Additionally, the DHCoE has an agenda for effectively reaching out to patients and offering them the latest healthcare services which significantly increases the quality of patient care. Also, DHCoE aims to create a large network of users which would allow seamless communication of patients with stakeholders such as healthcare professionals and device manufacturers. Such a network assures higher reliability and quick availability of healthcare services. Indeed, manufacturers may use the latest frameworks to build their systems, but they should make sure that their system has been subjected to enough testing to capture potential risks and possesses essential documentation that reflects the overall device quality, safety, and efficiency. To state briefly, their system should be compliant with the regulatory requirements.
To sum up, the platform of DHCoE emphasizes on modern healthcare services such as Digital Health using advanced technologies. Even though the DHCoE program is currently in its early stages, it is a platform that empowers medical device manufacturers to think outside of the box and deliver fine-tuned quality devices while complying with regulatory requirements. Do you have a medical device that is built using frameworks like Cloud Computing or AI and needs FDA approval? Our regulatory experts at EMMA International can help ensure your system is compliant with the regulatory requirements. Contact us at 248-987-4497 or info@emmainternational.com for additional information.
1FDA (September 2020). About the Digital Health Center of Excellence. Retrieved on October 11th, 2020 from https://www.fda.gov/medical-devices/digital-health-center-excellence.
2FDA (September 2020) Digital Health Center of Excellence Services. Retrieved on October 11th, 2020 from https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-center-excellence-services
3FDA (October 2020). Artificial Intelligence and Machine Learning in Software as a Medical Device. Retrieved on October 13th, 2020 from https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
