Christopher Delporte, Editorial Director03.13.14
A proposal for medical device interoperability standards from the U.S. Food and Drug Administration (FDA) may be available by April, according to officials from the FDA and the Office of the National Coordinator (ONC) of Health IT (information technology).
Agency officials spoke during a recent Health Care Innovation Day event hosted by the West Health Institute in Washington, D.C.
“We talked about the standards. We’ll continue the efforts. We’ll have more things rolling out,” Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a panel discussion with ONC and West Health representatives. “We’re going to put out draft guidance this coming year about how we think about interoperability and recommendations for how device developers should think about it.”
The agency has been working to address industry concerns, seeking input not just medical device makers but software manufacturers as well, according to the head of CDRH. He said multiple stakeholders have been “brainstorming” on the best procedures and how to move the process forward. The director told manufacturers that patients have the rights to their own data and acknowledged that cyber security is a challenge, noting that no system is foolproof. Interconnected devices, of course, come with a chance of hacking, but Shuren said his agency is attempting to examine all the risks.
Shuren added: “We’re not there yet. There’s more to do. Standards follow technology and [will always] play catchup.”
Karen DeSalvo, the national coordinator for health IT, said interoperability will be her office’s “top priority” for 2014, according to Healthcare IT News.
In an effort to boost care experience, improve population health and reduce costs, DeSalvo cited five ONC priorities:
Transparency Market Research recently published a report anticipating a 38 percent compound annual growth rate in the market for medical device connectivity through 2019, from $3.4 billion worldwide in 2012, and a report from West Health last spring predicted that the healthcare industry could save roughly $30 billion with improved interoperability in place, including $12 billion in savings from returning caregivers to the bedside rather than having them transcribing data from one device or system to another.
For example, the West Health report noted that 90 percent of hospitals use six or more types of devices that could be integrated with electronic health records (EHRs), while only a third integrate some EHRs with medical devices.
Agency officials spoke during a recent Health Care Innovation Day event hosted by the West Health Institute in Washington, D.C.
“We talked about the standards. We’ll continue the efforts. We’ll have more things rolling out,” Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, said during a panel discussion with ONC and West Health representatives. “We’re going to put out draft guidance this coming year about how we think about interoperability and recommendations for how device developers should think about it.”
The agency has been working to address industry concerns, seeking input not just medical device makers but software manufacturers as well, according to the head of CDRH. He said multiple stakeholders have been “brainstorming” on the best procedures and how to move the process forward. The director told manufacturers that patients have the rights to their own data and acknowledged that cyber security is a challenge, noting that no system is foolproof. Interconnected devices, of course, come with a chance of hacking, but Shuren said his agency is attempting to examine all the risks.
Shuren added: “We’re not there yet. There’s more to do. Standards follow technology and [will always] play catchup.”
Karen DeSalvo, the national coordinator for health IT, said interoperability will be her office’s “top priority” for 2014, according to Healthcare IT News.
In an effort to boost care experience, improve population health and reduce costs, DeSalvo cited five ONC priorities:
- Increasing health IT adoption;
- Establishing standards to enable medical technology interoperability;
- Providing incentives to help companies and organizations facilitate interoperability;
- Ensuring the privacy and security of personal health information; and
- Providing health IT governance and structure for industry.
Transparency Market Research recently published a report anticipating a 38 percent compound annual growth rate in the market for medical device connectivity through 2019, from $3.4 billion worldwide in 2012, and a report from West Health last spring predicted that the healthcare industry could save roughly $30 billion with improved interoperability in place, including $12 billion in savings from returning caregivers to the bedside rather than having them transcribing data from one device or system to another.
For example, the West Health report noted that 90 percent of hospitals use six or more types of devices that could be integrated with electronic health records (EHRs), while only a third integrate some EHRs with medical devices.