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Companies will identify best practices in cybersecurity benchmarking that can be replicated by manufacturers to ensure patient safety and security.
July 19, 2021
By: Michael Barbella
Managing Editor
The Medical Device Innovation Consortium (MDIC) has announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry’s cybersecurity maturity and create resources to measure maturity over time. The benchmark will serve as a critical source of information and further enable the industry to continue to improve product security. MDIC recognizes that healthcare is a critical infrastructure vital to the United States. Cybersecurity threats can have a debilitating effect on healthcare, national economic security, and national public health or safety. As such, MDIC is focused on making meaningful contributions to advance cybersecurity as it relates to medical devices. The goal of the Medical Device Cybersecurity Benchmarking Initiative is to measure cybersecurity maturity and benchmark across the industry to drive common improvements that reduce overall cybersecurity risk. “Both the technical solution and the programmatic structure proposed by the Booz Allen Hamilton team is well aligned with the cybersecurity vision of MDIC and its stakeholders. We look forward to working with their team to identify best practices in cybersecurity benchmarking that can be replicated by medical device manufacturers to ensure patient safety and security,” said Pamela Goldberg, MDIC president and CEO. Booz Allen Hamilton currently delivers advanced cyber solutions to the largest global medical device manufacturers; the company understands that lapses in security can lead to more than just financial and reputational damages. The firm will engage with medical device manufacturers and operationalize the Joint Security Plan’s cybersecurity maturity model. The data will be collected, aggregated, analyzed, and ultimately shared in a benchmark report made public by MDIC. This foundation and baseline will enable individual medical technology companies, Health Delivery Organizations (HDOs), and other stakeholders to more effectively establish long-term strategic plans to increase their cybersecurity maturity and efficiently track their progress. “We are thrilled to partner with MDIC and the medical device industry to create evidence-based tools and a benchmark of cybersecurity maturity. This is a critical next step in the evolution of the unique partnership across the whole industry, building on the JSP. Booz Allen is committed to maximizing patient safety and the healthcare sector’s resiliency through innovations in technology and security,” said Kelly Rozumalski, who leads Booz Allen’s secure connected health initiatives and health cybersecurity portfolio across the defense, federal and commercial markets. “As part of the FDA’s ongoing commitment to strengthening medical device cybersecurity, we are pleased to support MDIC’s Medical Device Cybersecurity Benchmarking Initiative. This initiative will measure maturity of cybersecurity best practices through adoption of the 2018 Healthcare Sector Coordinating Council’s (HSCC) Joint Security Plan (JSP). The JSP—an initiative co-led by FDA with the medical device industry and healthcare delivery organizations—articulates a total product lifecycle approach to medical device cybersecurity. By further advancing the adoption of the JSP, we can all work together to help transform the cybersecurity posture of medical devices from fragile to resilient,” said Suzanne Schwartz, director of the Office of Strategic Partnerships & Technology Innovation at the FDA’s Center for Devices and Radiological Health (CDRH). Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate the development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives aim to improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market.
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