MITA Releases National Standard for Medical Device Security

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

Washington, DC, October 09, 2019 --(PR.com)-- 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

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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 www.medicalimaging.org. Follow MITA on Twitter @MITAToday.-----

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Contact Information:
Medical Imaging and Technology Alliance
Tracy Cullen
703-841-3282
Contact via Email
https://www.medicalimaging.org/

Online Version of Press Release:

You can read the online version of this press release at: https://www.pr.com/press-release/796665

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