The Medical Imaging & Technology Alliance (MITA) on Wednesday, Oct. 9, published a new document to help healthcare practices protect medical devices from cybersecurity threats.
The voluntary standards—"EMA/MITA HN 1-2019, Manufacturer Disclosure Statement for Medical Device Security,” or MDS2—include a standardized form for manufacturers to complete with detailed information on the security features embedded in 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,” Dennis Durmis, chair of MITA's Board of Directors and senior vice president of Bayer Radiology, Americas Region, said in a statement. “With this standard, we aim to streamline communication and increase transparency of information between manufacturers and healthcare delivery organizations."
MITA worked with a “diverse group” of stakeholders to create the 39-page document. Its aim aligns with a playbook released by the FDA in October 2018, which sought to help healthcare organizations, manufacturers, government entities and other parties address threats to medical device cybersecurity.
Tim Walsh—member of the MDS2 Canvass Group, and principal information security analyst, CIS Operations, Mayo Clinic—called the standard “an important step” for both healthcare organizations and manufacturers in working to limit cybersecurity risks.
Download the entire standards document for free here.