Gain insight into global digital health industry requirements
UL provides security and interoperability testing, certification, and training solutions to device manufacturers and digital health industry IT developers to support market access and meet emerging global regulatory requirements. As an independent third-party, our work supports client’s seeking to improve product safety and demonstrate the steps taken to mitigate the emerging risks posed by connected medical devices and digital health industry software.
UL maintains multiple international accreditations to ensure independence and impartiality, allowing us to provide clients with objective insights and market-leading services. Leveraging longstanding partnerships with regulators, manufacturers, software developers, providers, and hospitals, UL staff can provide broad insight to the many digital health challenges facing clients in the marketplace.
Healthcare IT Certification (HIT)
UL is the first private IT Security laboratory accredited by the United States National Institute of Standards and Technology (NIST). Over the years, we have expanded our health IT certification services by investing in multiple formal accreditation programs, including:
- ONC HIT Certification Program – Authorized Testing Laboratory and Authorized Certification Body for Electronic Health Records (EHR)
- DEA EPCS Certification Program – Approved Certifying Organization
- EHR Product Certification List – Searchable list of UL certified products
- EPCS Certified Applications Lists – Searchable list of UL certified applications
Cybersecurity Testing in Healthcare
UL Engineers focus on promoting a “defense-in-depth” strategy for cybersecurity testing in healthcare aimed at reducing the likelihood of malicious users finding vulnerabilities at communication interfaces, reducing the likelihood of malicious users accessing critical aspects of the product when a vulnerability is found, and reducing the likelihood of malicious users increasing their level of access to other products or system assets with a successful breach. The threat of a major breach forces hospitals, providers, and product purchasers to closely review product cybersecurity testing and results in new requirements and longer procurement cycles.
UL helps clients meet evolving regulatory and marketplace challenges through independent cybersecurity testing evaluations and solutions designed to demonstrate the safety in healthcare and digital health products and devices.
There are a number of challenges preventing the health care community from realizing the full potential of device interoperability. These challenges include technical issues (the mechanics of interoperability), systems engineering issues (repeatable processes for correctly and efficiently integrating devices into larger systems), and overarching reliability, safety, and security challenges.
UL helps identify potential issues through assessments and verifications for technical, integration, and safety requirements to ensure devices meet expectations for interoperability.
Usability in Medical Devices and Healthcare IT
UL’s user experience and human factors specialists have helped many of the world’s leading health IT, medical device, and pharmaceutical companies apply usability in medical devices for healthcare and human factors engineering properly and comprehensively in the course of developing their products to ensure design excellence and market access. In addition to advising customers on the design and usability of HIT products, they help to ensure compliance with applicable standards.