SAFE Identity Launches Public Qualified Products List to Provide Secure, Lab-tested Identity Products to Healthcare Organizations
RESTON, Va., June 8, 2021 – SAFE Identity, an industry consortium and certification body supporting a standards-based, interoperable Trust Framework for digital identities, today announced the launch of the SAFE Identity Qualified Products List (QPL) program. The SAFE Identity QPL is the only public list that healthcare providers can use to find lab-tested identity related products and applications that support industry standards in PKI and cryptography. Testing ensures the products certified by SAFE correctly implement these standards to help healthcare organizations make more informed decisions about the products they buy.
How To Navigate Compliance With FDA s 21 CFR Part 11
By Kyle Neuman, managing director, SAFE Identity
21 CFR Part 11, the regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance whose companies are subject to inspections by the FDA. These companies include Contract Research Organizations (CROs) and pharma companies who operate clinical trials that produce records which fall into scope of the regulation. The FDA has released guidance on the 2,500-word regulation to bring more clarity to the scope and intent of its controls; however, compliance remains a moving target due to the nature of FDA inspections.
Group will establish industry standards for securely credentialing medical devices.
RESTON, Va. – March 2, 2021 – SAFE Identity, an industry consortium and certification body operating a Trust Framework for digital identities in healthcare, today announced the Internet of Medical Things (IoMT) working group. This group, composed of digital identity experts, will establish industry standards and guidance for medical device manufacturers to build trusted, secure and interoperable credentials into their products on the production line. This effort will enable hospitals, radiology centers, medical labs and other consumers of medical devices to use a trusted standards-based credential already on the device as soon as it arrives at their loading docks.