A leading medical-device industry lobbying group has launched a new advocacy center focused on digital health.
The Advanced Medical Technology Association's new Center for Digital Health will convene a group of companies from its membership to develop and advocate policy positions on issues affecting digital medical technology, such as data privacy, cybersecurity and artificial intelligence, the trade group said earlier this week.
The center's initial membership includes nearly 50 medical and digital technology companies, such as Apple, IBM, Medtronic, Pfizer and 23andMe. AdvaMed as a whole has more than 400 members.
"We expect, over time, more and more of our companies will be engaged on these issues," said Andy Fish, AdvaMed's chief strategy officer, of the center's digital health initiatives.
AdvaMed launched the center both to better coordinate its policy efforts, as well as to "ensure external stakeholders can see the work that we're doing, and engage with us accordingly," Fish said. In the past, this work was conducted through AdvaMed's digital health sector, an internal group now replaced by the Center for Digital Health.
It's the first center of its kind for AdvaMed, according to Fish. The group has five other so-called "sectors," organized around therapeutic areas like radiation therapy and orthopedics.
"Digital health is not a vertical segment of our companies, but is a set of issues that cuts across medical technology more generally," Fish said.
The center won't have its own dedicated budget separate from AdvaMed.
"It's shared resources across all our departments," Fish explained.
Last year AdvaMed spent $3 million on lobbying activities, according to campaign finance disclosure website OpenSecrets.org.
AdvaMed's launch of the center comes on the heels of a pair of guidances the Food and Drug Administration released last month, clarifying which types of medical software systems fall under the agency's regulatory oversight. That included a draft guidance proposing a new approach to regulating clinical-decision support software.
Assessing the FDA's plans for regulating digital health will be one of the Center for Digital Health's first priorities, said Zach Rothstein, AdvaMed's vice president for technology and regulatory affairs, and the group is in the midst of evaluating the agency's new draft guidance on clinical-decision support software.
Other priorities will include developing policy positions related to data stewardship and privacy, as well as advocating for reimbursement for digital health technologies, Fish said.