Establish the scope of the MDS2 Manufacturer Disclosure Statement for Medical Device Security. Voluntary industry-standard form jointly developed by NEMA Medical Imaging and Technology Alliance (MITA) and HIMSS (Healthcare Information and Management Systems Society) + first issued 2004 + revised 2008 + 2013 (NEMA HN 1-2013) + 2019 (NEMA HN 1-2019 most current widely-used) + 2022 update. Completed by medical-device manufacturers and provided to healthcare delivery organisations (HDOs) during procurement + maintenance + risk assessment to enable HDOs to evaluate cybersecurity posture. Aligned with FDA Premarket and Postmarket Cybersecurity Management of Medical Devices Guidance + FDA Section 524B of FD&C Act (Cybersecurity for Cyber Devices added by Consolidated Appropriations Act 2023 + effective 29 March 2023) + AAMI TIR 57 + AAMI TIR 97 + IEC 80001-1 + IEC 80001-2-2 + IEC 62443 + HIPAA Security Rule 45 CFR 164 Subpart C + Joint Commission accreditation standards LD.04.04.05 + IT.02.01.01 + Health Sector Coordinating Council (HSCC) Cybersecurity Working Group + Medical Device Innovation Consortium (MDIC) + H-ISAC + CISA Healthcare and Public Health Sector + ECRI Institute. Used by 75-80% of US HDOs for procurement evaluation. Internationally adapted including Health Canada Medical Device Cybersecurity Guidance + EU MDR Annex I + UK MHRA Software and AI as Medical Device + Australian TGA.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.