As information technology becomes increasingly important to health care delivery, it’s only logical that governments would begin to tighten oversight, something the European Union has done with its new medical device rules.
The rules are part of the revised Medical Devices Directive and are due to become law in 2010. For the first time, stand-alone software designed for diagnostic or therapeutic purposes will be classified as a medical device and will need to have the Conformité Européene, or CE Mark, before it can be released in the European market.
Consequently, radiological software and software used with handheld diagnostic devices — products that are designed to work with a range of systems — must be certified and tracked as medical devices separate from the products with which they work.
To some degree, software is already regulated as an intrinsic feature of many medical devices, said Claire McKenna, medical device program manager at the National Standards Authority of Ireland. “But now, if software can be used elsewhere or downloaded from the Internet and used by a physician for diagnostic purposes, then it can be considered a medical device,” she said.
The software ruling is one of the major changes to the directive, which has been in place in one form or another since 1993. Another change is the requirement for clinical data to support vendors’ claims for the performance and safety of their devices.
That requirement will make it harder for vendors to get the CE Mark for their products, McKenna said. Now sellers will have to more strongly support their claims, particularly for implantable and high-risk devices.
The good news for software vendors is that their products are not implantable and, therefore, probably would not be classed as high-risk devices, McKenna said.
The new regulations also require companies to establish a way to monitor their devices’ use and performance in the field.
Sentinel Initiative In the next few years, there will also be changes to the regulatory infrastructure in the United States, as the Food and Drug Administration and the Centers for Medicare and Medicaid Services seek to improve the safety of medical devices and drugs.
Their Sentinel Initiative, announced in May, will create an electronic system that will tap an array of databases, with the goal of using electronic health records and other health data to quickly and accurately detect possible safety concerns.
If it works as planned, the new system would provide information in near-real time and replace an existing system that can take years to show how a drug or medical device affects people.
Mike Leavitt, secretary of the Health and Human Services Department, said the new system is a quantum leap forward in FDA’s capacity to monitor the use of medical products.
“We are moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market,” Leavitt said.
Developers will create a prototype of the system by linking inpatient and outpatient claims data with prescription drug data under Medicare Part D, which has information on the prescription drug use of more than 25 million people.
The FDA Amendments Act of 2007 sets a target of July 1, 2010, for access to that data and a goal of generating data on as many as 100 million patients two years later.
According to FDA, the new system should not pose an additional burden for device makers because it’s designed to work with existing surveillance tools. Industry leaders will also have the opportunity to share concerns and ideas.
The same is not true overseas. If firms want to market their products in Europe, they must comply with the EU’s directive.
Government Health IT will present Liesa Jo Jenkins, executive director of CareSpark, in an eSeminar at 11 a.m. Thursday, Oct. 16, where she will share her experiences and insight into building a health information exchange that enhances community health, rewards regional collaboration and drives economic progress.
