MITA Releases National Standard for Medical Device Security

MDS2 Standard Promotes Shared Responsibility Between Healthcare Delivery Organizations and Device Manufacturers.

MITA Releases National Standard for Medical Device Security
Washington, DC, October 09, 2019 --( The Medical Imaging & Technology Alliance (MITA) today announced the publication of NEMA/MITA HN 1-2019, Manufacturer Disclosure Statement for Medical Device Security, also known as MDS2. This voluntary Standard supports security risk management within healthcare delivery organizations by providing standardized information on security control features integrated within medical devices.

“MITA recognizes that cybersecurity is a shared responsibility among all involved market participants, and it requires health delivery organizations especially to work collaboratively with manufacturers to ensure the use of best practices,” said Dennis Durmis, Senior Vice President Bayer Radiology, Americas Region, and Chair of MITA Board of Directors. “With this Standard, we aim to streamline communication and increase transparency of information between manufacturers and healthcare delivery organizations.”

The Standard, whose development was led by MITA in conjunction with a diverse group of interested parties, includes a form intended to provide healthcare delivery organizations with crucial information and security control features within medical devices. It also clarifies the roles of manufacturers and healthcare delivery organizations in ensuring the security of medical devices.

“This Standard is an important step in the collaborative efforts between health delivery organizations and manufacturers to mitigate cybersecurity risk,” said Tim Walsh, Principal Information Security Analyst – CIS Operations, Mayo Clinic, and member of the MDS2 Canvass Group. “Transparent information and speed of getting that information from manufacturers to health delivery organizations are crucial, and this Standard helps foster both.”

The shared responsibility recognized by this Standard is aligned with the position of the U.S. Food and Drug Administration (FDA), which released a preparedness and response “playbook” last October to help healthcare delivery organizations address threats to medical device cybersecurity. Recognizing that manufacturers, hospitals, health care providers, cybersecurity researchers, and government entities all have roles to play in addressing threats to medical device cybersecurity, the playbook serves as a valuable resource to healthcare delivery organizations as they develop their individual emergency response plans.

“We look forward to further engaging with our partners over the next several months to ensure the MDS2 Standard is appropriately implemented across the sector,” Durmis concluded.

To view the Standard, click here.

The Medical Imaging & Technology Alliance (MITA) is a Division of NEMA – an ANSI-certified Standards Developing Organization -- and the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit Follow MITA on Twitter @MITAToday.­­­­­
Medical Imaging and Technology Alliance
Tracy Cullen