FDA Encourages Interoperability – Factors for Healthcare IT to Consider

JonathanDraper-200By Jonathan Draper, Director of Product Management, Healthcare, Calgary Scientific
Twitter: @calsci

True Interoperability Must Be Designed
Every day, hospitals and health systems across the country struggle with exchanging patient data between electronic health records, PACS and other health information systems. In a recent survey, for example, accountable care organizations (ACOs) cited lack of interoperability as their number one challenge to achieving improved, patient-centered care. To solve this problem, legislators, industry associations, public-private partnerships and more are calling for industry standards, frameworks and legislation that support simple and safe patient data exchange. On January 26th, the FDA joined this industry-wide chorus with the release of a draft guidance titled “Design Considerations and Pre-Market Submission: Recommendations for Interoperable Medical Devices.”

FDA guidance documents, while they are not rules or requirements, include elements of design that medical device manufacturers should consider during product development. One of the FDA’s key recommendations is to “design systems with interoperability as an objective.” With the complexities of today’s health IT environments, this is the right approach. An enterprise image-viewer, just as one example, needs multiple features to interoperate with electronic health records (EHRs), PACS, VNAs and more.

The interoperability requirements for enterprise image-viewers include the following:

  • Support for multiple image storage and access systems. Patient images are stored in multiple and diverse systems, including PACS, VNAs and EHRs, each of which has a unique structure for image storage that enterprise image-viewers must support.
  • Connectivity to networks and clouds, both local and remote. Patient image locations are fragmented among clinics, hospitals, physician offices and the cloud, so enterprise image-viewers must support multiple communications and connectivity standards.
  • Secure and safe access to protected health information. Security is critical to safe patient data exchange, so any enterprise image-viewer that supports interoperability must also support standard security protocols and frameworks.
  • Usability across multiple systems. A single interface is also key to interoperability, allowing providers to access images without having to learn new menus and workflows for each network or image storage system.

This level of complexity cannot be “added on” to meet interoperability needs. Each element must be included in the core of a product’s design with the flexibility to adjust to new standards and systems as they appear in the market. The risk in failing to design for interoperability will leave you having to spend significant time and money refactoring your solution to work with new systems in the enterprise.

This article was originally published on Calgary Scientific and is republished here with permission.