IEEE Develops Standards For Medical Device Interoperability, 3D Printing
By Jof Enriquez,
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The Institute of Electrical and Electronics Engineers Standards Association (IEEE-SA) unveiled recently new interoperability standards for medical devices, 3D printers, and other eHealth devices. The professional association also announced a collaboration with the Regenstrief Institute for the uniform use of medical terminology in device communications.
IEEE currently is developing IEEE P2650, Draft Standard For Enabling Mobile Device Platforms To Be Used As Pre-Screening Audiometric Systems, specifically for the first-level assessment of hearing in infants.
“Screening and diagnosis of hearing impairment is typically today performed by trained audiologists and/or clinicians using specialized equipment. IEEE P2650 is being developed to enhance mobile platforms and linked portable/wearable devices,” stated IEEE, per Health Data Management. “When completed, the standard is intended to establish performance, interoperability and validation requirements of the devices and software used for audiometric prescreening.”
Development work also is ongoing for IEEE P3333.2.5, Draft Standard For Bio-CAD File Format for Medical Three-Dimensional (3D) Printing. This standard would ensure that 3D printers follow standard methods to print 3D-printed prosthetics and medical devices.
“High reliability in producing useful and cost-effective products is especially important in medical 3-D printing,” the IEEE statement explained, according to Health Data Management. “When completed, the standard is intended to address medical 3-D printing services, such as anatomic and pathologic models and medical-instrument printing.”
IEEE also announced the signing of a Memorandum of Understanding (MoU), between the association and the Regenstrief Institute, to develop standard medical terminology to be used in IEEE 11073 standards; the standardized terminology is being used to ensure interoperability among point-of-care personal health devices, such as those used by patients with chronic diseases like asthma, diabetes, heart failure, and chronic obstructive pulmonary diseases (COPD). The Regenstrief Institute operates the Logical Observation Identifiers Names and Codes (LOINC) database of medical nomenclature, and IEEE says it will collaborate with the Institute and the U.S. National Institute of Standards and Technology (NIST) to enhance IEEE 110073 standards.
“The IEEE-SA's efforts in eHealth are all focused on expanding interoperability standards and supporting the growth of the eHealth ecosystem and new life-saving capabilities,” said Konstantinos Karachalios, managing director, IEEE-SA, in a statement. “Through both standardization and collaboration, the IEEE-SA strives to improve the quality of eHealth and the wellbeing of people worldwide by providing a global platform for eHealth stakeholders across regions and technologies to openly collaborate and build consensus. The new partnership and standardization milestones that we are announcing today are evidence of this effort.”
Besides the two draft standards and the MoU, IEEE also unveiled IEEE 2410-2015, or the Biometrics Open Protocol Standard (BOPS). According to Mobile ID World, the new eHealth standard was designed to protect biometric data exchange, specifically, data transmission from client device software (running on smartphones and other mobile devices), ensuring that such data is sent to a trusted BOPS server, and with an intrusions detection system in place.
Cybersecurity has become a top concern for device manufacturers, and IEEE, as a standard-setting organization, has been helping the medtech industry tackle the threat of interconnected, but unsecured, medical devices. In May, IEEE released guidelines, called "Building Code for Medical Device Software Security,” to promote medical device software security. The U.S. Food and Drug Administration (FDA) also released a cybersecurity guidance.