Requirements ยท Healthcare
IEC 80001-1
Risk management for IT networks incorporating medical devices. 2 Moraph products list it under “Requirements it supports”. The products support this requirement; meeting it remains your organization’s responsibility.
About the rule
What it is
IEC 80001-1:2021, Application of risk management for IT-networks incorporating medical devices, is an international standard published by the International Electrotechnical Commission. It sets requirements for organizations, such as health care delivery organizations, that apply risk management to safety, effectiveness and security when connecting medical devices and health software to their IT infrastructure. It replaced the 2010 first edition.
Source: IEC webstore: IEC 80001-1:2021. This summary is for orientation only; read the rule itself or ask your counsel for what it requires of you.
Citations
How the products cite it
The exact wording on the product pages, with how many products use each.
- ANSI/AAMI/IEC 80001-1 (safety, effectiveness and security in networks incorporating medical devices) 1 product
- IEC 80001-1 risk management for health IT networks incorporating medical devices 1 product
For what it requires of your organization, read the rule itself or ask your counsel.
Products
The 2 products that support it
Medical Device Cybersecurity Hub
Inventory of IoMT (Internet of Medical Things) devices, tracking patch status and vulnerabilities.
Lists:
- ANSI/AAMI/IEC 80001-1 (safety, effectiveness and security in networks incorporating medical devices)
Network Access Control
Quarantining unknown medical devices that plug into hospital wall jacks.
Lists:
- IEC 80001-1 risk management for health IT networks incorporating medical devices
Not sure which requirements apply to you? Request a gap analysis. All requirements: Requirements our products support.