Health Data Privacy and Security Assessment

Our Client developed a lightweight software security solution for wearable medical devices that maximizes battery life, conserves memory, and ensures uncompromised functionality.  To develop a clear and compelling value proposition for the adoption of the Solution by wearable ECG device manufacturers, the Client needed to demonstrate how the Solution facilitates compliance with health data privacy and cybersecurity regulatory requirements.

PASB conducted an in-depth analysis a generated a comprehensive report outlining the health data privacy and cybersecurity requirements applicable to battery-operated ECG wearable medical devices in key markets. The report provided vital insights including:

• Regulatory Requirements: A breakdown of relevant health data privacy and security regulations in the United States (by State), Canada (by Province), and the European Union.
• Guidance on Customer Communication: Identification of key information to share with customers to demonstrate how the security solution mitigates privacy and cybersecurity risks without introducing new risks.
• Legislative Framework and Key Concepts: A detailed discussion of laws, concepts, and keywords associated with health data privacy and cybersecurity requirements in the US, Canada, and EU that are relevant to wearable medical device manufacturers.
• Device-Specific Requirements: A discussion of regulatory expectations for Class II remote patient monitoring devices.

 

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