The National Electrical Manufacturers Association (NEMA) published HIMSS/NEMA HN 1-2013 Manufacturer Disclosure Statement for Medical Device Security.
The HN 1 standard consists of the Manufacturer Disclosure Statement for Medical Device Security (MDS2) form and related instructions on how to complete it. The intent of the MDS2 form is to supply healthcare providers with important information to assist them in assessing the vulnerability and risks associated with protecting private data transmitted or maintained by medical devices and systems. Major changes from the previous edition include:
- alignment of MDS2 with IEC 80001-1 Application of Risk Management for IT Networks Incorporating Medical Devices—Part 1: Roles, Responsibilities and Activities and IEC/TR 80001-2-2 Application of Risk Management for IT Networks Incorporating Medical Devices—Part 2: Guidance for the communication of medical device security needs, risks and controls
- MDS2 data requested of device manufacturers has been increased to more adequately address the 19 security capabilities of IEC/TR 80001-2-2
HIMSS/NEMA HN 1-2013 may be viewed at no cost on the NEMA website.
NEMA is the association of electrical equipment and medical imaging manufacturers, founded in 1926 and headquartered in Arlington, Virginia. Its 400-plus member companies manufacture a diverse set of products including power transmission and distribution equipment, lighting systems, factory automation and control systems, and medical diagnostic imaging systems. Total U.S. shipments for electroindustry products exceed $100 billion annually.
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