By: Bakul Patel
Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health.
Some of these systems, referred to as "medical device data systems," are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices.
Medical device data systems can collect and store data from a variety of other medical devices, including glucose meters, blood pressure cuffs, and weight scales. This data can be used at home to track certain information or it can be stored for a doctor to review at a later time.
Medical device data systems can be used in hospitals to collect information and data from other medical devices including bedside monitors and infusion pumps. This information can then be stored in a patient’s electronic health record for a more complete review of a patient’s total health.
In 2011, FDA issued a regulation down-classifying medical device data systems. Since that time, FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.
Today, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.
Why would we do that?
Since our 2011 action, we’ve been working with two other federal agencies that oversee health IT – The Office of the National Coordinator for Health IT (ONC) and the Department of Health and Human Services, and the Federal Communications Commission (FCC) on a proposed risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. In the course of our work on the proposed framework, we sought extensive public feedback. And we listened.
In light of those discussions, we believe that medical device data system products pose little risk. While every medical device and procedure carries a certain level of risk, the health IT report proposes a risk-based framework – where we use our regulatory tools, resources, and expertise where they are most needed – and that’s with devices that carry greater levels of risk.
This allows developers of medical device data systems to focus on making these products better able to operate amongst various devices and technology systems – resulting in stronger products.
Today’s proposed guidance for manufacturers of medical device data systems is thus consistent with the health IT report we issued earlier this year with ONC and FCC on the proposed framework. That report placed health IT products in three categories according to their risk to patients. FDA’s regulatory oversight of health IT products is focused on the devices that pose higher risk to patients.
Medical device data systems are critical to the success of digital health because they transfer, store, convert, and display a variety of information from medical devices critical to understanding an individual’s health. These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT.
Because they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. FDA believes that this will encourage greater innovation in the development and maturation of these systems.
Bakul Patel is senior policy advisor in FDA’s Center for Devices and Radiological Health.
