Compared to the Facebook data “scandal” that has garnered worldwide media attention, the issue of cybersecurity as it relates to digital or connected mobile medical devices doesn’t get many headlines, but it is gaining significance in the healthcare community.
A March 22 Out-Law.com article, for example, points to ransomware attacks that “put the privacy and integrity of patient data at risk.” The story focuses on a new Royal Academy of Engineering report that calls for “new guidance to provide a ‘benchmark for regulatory compliance’ on cybersecurity in the supply chain.”
RAE’s 52-page “Cyber safety and resilience” report says, “Cyberattacks on connected health devices are increasingly a concern as they could have severe, or even life-threatening, consequences on patient safety.”
The report lists numerous recommendations to meet complex cybersecurity challenges to “produce trustworthy, regulated products that work to medical standards and have good cyber security, but at the speed, efficiency and price of consumer products.”
In the report’s table of conclusions, RAE lists two vertical columns, one for general findings and principles, as well one for application to the health sector as they relate to horizontal topics of vulnerabilities, regulation, governance, and procurement and the supply chain.
Regarding the supply chain, the report notes, “Cyber labels could help procurers and end-users, whether staff or patients, to understand the product better. The consumer of connected health devices also requires clear information on the cybersecurity of products that they are purchasing. A trusted source of information is necessary, which may provide online support or solutions. Pharmacists could play an important role here.”
Despite the challenges presented by cybersecurity issues, consumer/patient acceptance of smartphones coupled with increasing apps for mobile/connected medical devices are gaining momentum.
“Analytics-driven intelligent medical devices have led to better safety, improved outcome accuracy, efficient patient monitoring, and reduced recovery times,” notes “Pharmaceutical & Medical Devices Trends & Opportunities in Packaging Operations 2016,” a research report from PMMI, The Association for Packaging and Processing Technologies.
