- NLM Digital Collections - FDA should further integrate its review of cybersecurity into the premarket review process ...Publication: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018FDA should further integrate its review of cybersecurity into the premarket review process for medical devices ... Why OIG Did This Review. Cybersecurity is an area with increasing risk to patients and the health care industry as more medical devices use wireless, Internet, and ...
- NLM Digital Collections - Cybersecurity : HHS defined roles and responsibilities, but can further improve collaboration ...Publication: Washington, DC : United States Government Accountability Office, June 2021Cybersecurity : HHS defined roles and responsibilities, but can further improve collaboration : report to Congressional requesters ... guidance have set requirements for HHS to address cybersecurity within the department and the sector. Federal guidance ...
- NLM Digital Collections - Cybersecurity. NIH needs to take further actions to resolve control deficiencies and improve ....Publication: Washington, DC : United States Government Accountability Office, December 2021Cybersecurity. NIH needs to take further actions to resolve control deficiencies and improve its program : report to ... the agency’s systems. GAO was asked to examine cybersecurity at NIH. In June 2021, GAO issued a ...
- NLM Digital Collections - Medicare lacks consistent oversight of cybersecurity for networked medical devices in ...Publication: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, June 2021Medicare lacks consistent oversight of cybersecurity for networked medical devices in hospitals ... Why OIG Did This Review. Without proper cybersecurity controls, ... internet, hospital networks, and other medical devices) can be compromised, ...
- NLM Digital Collections - Cybersecurity in medical devices : refuse to accept policy for cyber devices and related ...Publication: Silver Spring, MD : Center for Devices and Radiological Health, March 30, 2023Cybersecurity in medical devices : refuse to accept policy for cyber devices and related systems under section 524B ... into law. Section 3305 of the Omnibus - “Ensuring Cybersecurity of Medical Devices” - amended the Federal Food, Drug, ...
- NLM Digital Collections - Cybersecurity in medical devices : quality system considerations and content of premarket ...Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2023Cybersecurity in medical devices : quality system considerations and content of premarket submissions : guidance for industry and Food ... information and other information, the need for robust cybersecurity controls to ensure medical device safety and effectiveness ...
- ... These evaluations included device performance, safety, workflow, interoperability, cybersecurity, maintenance, user experience, and cost of ownership. 75 ...
- ... technology for a flexible workplace; and (5) embedded cybersecurity protections. To guide these efforts, the Information Technology, Cyberinfrastructure, and Cybersecurity (ITCC) Working Group of the Advisory Council to ...
- ... any large databases, registries may be vulnerable to cybersecurity threats. Registries should assess these risks and develop ... components described below. However, a full discussion of cybersecurity as it relates to registries is beyond the ...
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