Tag Archives: cybersecurity

Cybersecurity

Preparing for the PATCH Act and RTA

By MedTech Intelligence Staff
Cybersecurity

The FDA announced that on October 1, 2023, it would begin to Refuse to Accept (RTA) medical device premarket submissions that do not comply with PATCH Act requirements. Erez Kaminski, former head of AI with Amgen and founder of  Ketryx, and Paul Jones, former FDA official and Executive Vice President of Ketryx, provide an overview of challenges companies face as they work to comply with the new cybersecurity regulations and standards.

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Gabe Siftar and Matt Nowell

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

By Gabe Siftar, Matt Nowell
Gabe Siftar and Matt Nowell

The recently announced “Refuse to Accept Policy” signed into law under section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA more traction to encourage the medical device manufacturing industry to utilize software bills of materials that help to incorporate supply chain security. The ISA/IEC 62443 series of standards defines a secure product lifecycle process that can be adopted by medical device manufacturers to identify and manage the security risks of all external components used within the product.

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Brad Jolly
MEDdesign

Five Critical Considerations for Connected Health Manufacturers

By Brad Jolly
Brad Jolly

Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration.

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Darren Porras and Stuart Kozlick, RTI
MEDdesign

Intelligent Software Connectivity: An Opportunity to Transform Device Development and Health Care

By Darren Porras, Stuart Kozlick
Darren Porras and Stuart Kozlick, RTI

MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems, and device manufacturers are faced with significant challenges in bringing these connected solutions to market. Slow and expensive development lifecycles, complex and inflexible device architectures, and the need for increased cybersecurity, are among the key challenges. The solution lies in a new generation of devices powered by intelligent software data flow.

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Cybersecurity

Managing Legacy Technology Security

By MedTech Intelligence Staff
Cybersecurity

A new guide from the Healthcare and Public Health Sector Coordinating Council recommends cybersecurity strategies that manufacturers and health providers can implement for legacy medical technology as a shared responsibility in the clinical environment, and provides insights for designing future devices that are more secure.

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