EU Proposed Cybersecurity Regulation

The EU has proposed a new regulation on cybersecurity.  While this regulation is not specific to the health sector, health is mentioned as critical infrastructure in the proposal. The proposal would provide a revised mandate, objectives, and tasks for ENISA, the “EU Cybersecurity Agency.”  The new tasks include:

  1. Facilitating the establishment and take-up of European and international standards for risk management and security of ICT products and services.
  2. Supporting and promoting the development and implementation of the EU policy on cybersecurity certification of ICT products and services.

The framework for an EU cybersecurity certification is established in this proposed regulation.

View all of our resources related to cybersecurity under our Library Cybersecurity page.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@softwarecpr.com
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