FDA Outlines Path For Guidance On Clinical Decision Support Tools

Article preview from "The Gray Sheet"- September 19, 2011

CDRH officials are looking for ways to better define when and how clinical decision support tools included in mobile health applications or medical software should face FDA regulation.

FDA Outlines Path For Guidance On Clinical Decision Support Tools

Article preview from "The Gray Sheet"- September 19, 2011

The center is preparing to draft guidance on the burgeoning product class. To aid that effort, officials led discussions on the benefits and risks of the tools during a Sept. 13 public meeting on mobile medical applications at FDA headquarters in Silver Spring, Md.

Clinical decision support can be defined quite broadly as any tool that takes health-related data and converts them in some way for a patient, caregiver or clinician to use in making a medical decision related to diagnosis or treatment.

Actionable data imported to a clinical decision support tool might include blood glucose levels, other patient-specific information, or even environmental data such as local pollen counts, FDA says. Then algorithms or other methods are employed to transform the data into usable decision support.

The tools have broad potential applications for assisting patients, caregivers or clinicians.  Some of the systems have even attracted the attention of insurers including Medicare as a means to keep health care costs under control by prompting providers to follow evidence-based guidelines.

Continued...

To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to Medtech Insight Newsletter.

About Medtech Insight

Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices.

Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512