The FDA has recently announced the establishment of a new Digital Health Advisory Committee. This committee has been established with the intent of furthering the study of digital health technologies- DHTs and aiding in the understanding of the intricate scientific and technical issues associated with them.
Digital health, which encompasses various technologies and devices such as AI, machine learning, digital therapeutics, augmented reality, virtual reality, wearables, remote patient monitoring, and software, is experiencing rapid advancements. These advancements enable discussions on decentralised clinical trials, patient-generated health data, as well as cybersecurity. Moreover, the utilisation of these advances is enabling significant progress towards health equity by providing remote accessibility for patients.
However, DHTs can also pose a risk to patient security if they are not developed through stringent testing and utilised effectively.
Digital health technology cybersecurity has been a significant topic of discussion this year. The FDA has released guidance on cybersecurity device design, labelling, and documentation, both before and after the product is on the market. In addition, the administration has implemented new regulations that mandate the protection of any medical device using software to gather and communicate data against cybersecurity threats.
Section 3305 of the Consolidated Appropriations Act of 2023, also known as the US Omnibus Bill, contains provisions specifically addressing medical device cybersecurity. These provisions go on to include requirements for device manufacturers to offer adequate confidence that their products are cybersecure and can be updated as well as patched to fix vulnerabilities. Additionally, manufacturers must provide documented evidence, such as a software bill of materials, for open-source, commercial, and off-the-shelf software parts.
The digital health committee’s main responsibility is to provide advice to the administration on various issues related to digital health technologies. This includes assessing the risk of cybersecurity breaches and other relevant matters. The committee will contribute their knowledge and viewpoints in order to enhance understanding of the advantages, hazards, and outcomes associated with specific technologies in this field.
When announcing the committee, MD, JD, and director Jeff Shuren of the FDA’s Centre for Devices and Radiological Health pointed out the importance of leveraging both internal and external knowledge so as to effectively apply regulatory authority. This approach aims to safeguard patient health while continuing to promote innovation in the rapidly advancing field of digital health technologies.
The committee will be composed of 9 voting members, which includes the chair. These members will possess a wide range of technical as well as scientific expertise, coming from diverse backgrounds. Additionally, interim participants will be selected for specific meetings based on the topic at hand. According to the FDA, this will help ensure that digital health medical devices are created and aimed at meeting the needs of different groups.
They are thrilled to have a committee of experts from various fields who can assist in regulating the rapidly advancing technology. Their objective is to ensure that the regulations keep up with the rapid development of these thrilling tools while sticking to safety and effectiveness norms,” stated Troy Tazbaz, the director of the FDA’s Digital Health Centre of Excellence, in one of the press releases. It is essential for them to acknowledge that many of these technologies are new and constantly evolving. Therefore, it is their responsibility to acquire as much information about them as they can. This will enable them to establish and enforce regulations that strike a balance between fostering creativity and safeguarding public health.
The FDA has indicated that the committee is expected to be fully operational by 2024.
The news about the formation of a digital health tech division by the Advanced Medical Technology Association- AdvaMed comes shortly after their announcement. This division will be represented by medical technology companies and aims to highlight the value of data and digital medtech in driving healthcare innovation. The group’s main areas of focus will include policies related to rules, payment and delivery of healthcare, data stewardship and confidentiality, and cybersecurity.
