Sherrill Introduces Legislation to Improve Patient Data Access

WASHINGTON, DC —  Representative Mikie Sherrill (NJ-11) introduced the Patient Device Data Access Act, which will allow the FDA to require manufacturers of remotely monitored medical devices to share health data with a patient upon their request. Rep. Sherrill worked alongside a NJ-11 constituent, Gretchen, who suffers from a rare heart condition called Hypertrophic Cardiomyopathy (HCM) and has an implanted defibrillator which is remotely monitored. Sherrill and Gretchen have worked together to develop this legislation that would empower patients to advocate for their own health while protecting their data privacy. 

“Years ago, after the sudden cardiac death of her 19 year old son, Gretchen came to my team to share her experiences trying to access her personal health data from the medical device treating her rare heart condition, and the importance that accessing this data would have for managing her health,” said Rep. Sherrill. “Together, we’ve worked to introduce the Patient Device Data Access Act in order to give patients more autonomy and ability to receive their own medical information from remotely monitored medical devices in order to improve personal health outcomes.” 

The Patient Device Data Act would give the FDA Administrator the authority to require the manufacturers of remotely monitored medical devices to share all patient data with patients upon their request. The bill directs the FDA Administrator to consider certain guidelines when establishing this requirement for manufacturers, including publicly disclosing how patients can request their data and what types of data the remotely monitored device collects or transmits; notifying patients that they can access this data; and disclosing data in a format that is understandable for patients.  

Remote monitoring implanted medical devices are critical to treating health conditions like Gretchen’s. More than 350,000 people experience sudden cardiac arrest outside of the hospital each year and nearly 90% are fatal. For those with health conditions like HCM, remote monitoring implanted medical devices are necessary and can be lifesaving. This legislation is critical to ensuring that individuals with cardiac device implants or any other remotely monitored medical devices have access to data about their own health and are able to advocate for themselves with doctors and medical professionals. 

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