FDA’s medical device arm ramps up HIT strategies

The Food and Drug Administration’s Center for Devices and Radiological Health has released its regulatory science priorities for fiscal year 2017, which starts on October 1, with a heavy emphasis on health information technology.

The document from FDA’s Center for Devices and Radiological Health (CDRH)—which is responsible for assuring the safety, effectiveness, performance and quality of medical devices and radiation-emitting products used to treat, prevent, and diagnose disease—lays out its top regulatory science priorities for FY17.

“Health IT is critical to those strategic priorities in order to develop, generate and integrate high-quality evidence for regulatory decision-making,” says Bakul Patel, associate director of digital health in the Center for Devices and Radiological Health at FDA.


CDRH’s FY17 regulatory science priorities include:

· Leveraging big data for regulatory decision-making.

· Developing methods and tools to improve and streamline clinical trial design.

· Enhancing the performance of digital health and medical device cybersecurity.

· Developing computational modeling technologies to support regulatory decision-making.

· Collecting and using patient input in regulatory decision-making.

· Leveraging precision medicine and biomarkers for predicting medical device performance,

The use of big data, in particular, offers a wealth of scientific and clinical information relevant to medical devices, the FDA says.

“Data from real-world experience, insurance, Medicare and Medicaid claims, clinical trials, imaging and next-generation sequencing can help improve medical device designs, become training sets for artificial intelligence devices or be used to develop precision diagnostics,” according to CDRH. “Information from these data warehouses can also help detect potential emerging post-market issues.”

CDRH wants to harvest, validate, organize and disseminate information in data warehouses to streamline regulatory decision-making throughout the medical device product lifecycle. The agency asserts that “it is fundamental to develop the necessary infrastructure, statistical or analytical tools and models, information retrieval and processing for big data, relevant to enhancing safety, performance and quality of medical devices.”

Research is also needed to enhance the performance and cybersecurity of medical devices and software, asserts CDRH.

“Digital health products such as mobile medical apps have the potential to transform healthcare by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional healthcare settings, help consumers manage their own health and wellness, and also gain access to useful information when and where they need it,” adds Patel, who says the FDA’s current approach to these products seeks to balance patient safety while encouraging innovation in new health technologies.

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“We plan to enhance this through continued work with stakeholders to clarify our regulations, provide resources for digital health technology developers and build our capacity to evaluate the evolving world of software-based, connected medical devices,” Patel says.

When it comes to strengthening medical device cybersecurity, he said the FDA has expanded the scope of its work in cybersecurity over the past several years and will continue to use its authority to contribute to more secure medical devices.

“We have worked diligently to bring the healthcare community together to propose and implement shared solutions to addressing cybersecurity concerns,” contends Patel. “We can and have delayed medical devices from coming to market until cybersecurity controls were considered adequate and residual risks were considered acceptable.”

In addition, he says the regulatory agency has proposed new guidelines that outline how manufacturers should be identifying, addressing and mitigating cybersecurity vulnerabilities after their devices are in use. Further, Patel believes the FDA has the authority to take action when quality systems regulations are violated.

“As a result, we are starting to see a shift in mindset among all stakeholders—manufacturers are realizing the importance of implementing comprehensive cybersecurity controls throughout a product’s lifespan, hospitals are taking steps to secure their networks, healthcare professionals are becoming more aware of cybersecurity concerns, and independent security researchers are performing valuable research to identify cybersecurity vulnerabilities before they have the potential to harm patients,” he concludes. “Working together in a trusted, open environment across stakeholders will allow us to better address device safety.”

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