ISO 20737 is titled:
“Health informatics — Security and privacy requirements for software for implantable medical devices”
The standard specifies:
ISO 20737 is essential for medical device manufacturers, software developers, and healthcare providers focused on patient safety and data protection in implantable technologies.
Implantable medical devices, such as pacemakers, insulin pumps, and neurostimulators, increasingly rely on software for their operation. The connectivity of these devices introduces risks:
ISO 20737 helps organizations address these challenges by embedding security and privacy-by-design principles into device software, reducing risks and ensuring compliance with healthcare regulations like HIPAA, GDPR, and FDA guidance.
Adopting ISO 20737 benefits organizations by providing:
Implementing ISO 20737 can significantly improve your business operations and market standing:
Meets cybersecurity and privacy requirements mandated by healthcare regulators worldwide.
Minimizes risk of device-related incidents due to software vulnerabilities.
Demonstrate commitment to security and privacy in implantable device software.
Build stronger relationships with healthcare providers and patients by ensuring data safety.
Encourages secure software development practices, enabling new features with reduced risk.
Enables monitoring and response to emerging cybersecurity threats throughout the device lifecycle.
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