Cybersecurity measures

Committee:
Medical Equipment
status:
Progress
Published:
In the revision of the Ministry of Health, Labour and Welfare guidelines, the application of two-factor authentication to medical devices was considered. In cooperation with other industry associations, the EBC took the lead together with the authorities and recommended a regulatory design that takes into account feasibility in clinical settings and alignment with international cybersecurity requirements.

Recommendations

  • We propose that industry, including manufacturers, be included as members in deliberations on cybersecurity-related measures.
  • We propose ensuring consistency with international standards and global regulatory trends when developing regulations and guidelines on cybersecurity measures.