The register
Every clause and element of ISO 81001-1, in the document's own order
The public record carries the structure: seven core themes in Clause 4, eight foundational elements in Clause 5, four term groups in Clause 3 and three informative annexes. Each row below is one page. Where the draft text is not public, the page says what the record carries and what it does not.
27 clause and element rows3 annex rows120 evidence lines120 common gaps
| Clause | Row | The answer in one line | Status |
|---|---|---|---|
| 1 | Scope | The document fixes the shared principles, concepts and terms for safety, effectiveness and security of health software and health IT systems across the whole life cycle, from concept to decommissioning, and names the points where responsibility passes between parties. | Normative |
| 2 | Normative references | The public record does not list the normative references of the draft. A reference list decides which other editions bind, so it must be read from the published text, never assumed. | Normative |
| 3 | Terms and definitions | The first edition grouped its terms into four families: organisations, people and roles; key properties and processes; health information and technology; and risk management. The draft's own definitions are not public. | Normative |
| 3.1 | Organisations, people and roles | The first edition's first term group covers organisations, people and roles. The draft's definitions are not public. | Normative |
| 3.2 | Key properties and processes | The second term group covers the key properties and the processes that maintain them. The draft's definitions are not public. | Normative |
| 3.3 | Health information and technology | The third term group covers health information and technology. The draft's definitions are not public. | Normative |
| 3.4 | Risk management | The fourth term group covers risk management. The draft's definitions are not public. | Normative |
| Clause | Row | The answer in one line | Status |
|---|---|---|---|
| 4 | Core themes | Clause 4 carries the themes of the document: the sociotechnical ecosystem, the system of systems, the life cycle, roles and responsibilities, communication, and the interdependence of the three properties. | Normative |
| 4.1 | General | The opening sub-clause states the themes that the rest of Clause 4 develops. Its text is not public. | Normative |
| 4.2 | Sociotechnical ecosystem | Health software works or fails as a sociotechnical arrangement: the people, the tasks, the technology, the organisation and the environment together. The draft's text is not public. | Normative |
| 4.3 | System of systems | A health IT system is one system among many, and the behaviour that matters emerges from the connections. The draft's text is not public. | Normative |
| 4.4 | Life cycle of health software and health IT systems | The document follows the system from concept to decommissioning and treats the whole life as the scope of assurance, not only development or go-live. | Normative |
| 4.5 | Roles and responsibilities | Responsibility moves across the life cycle. The document requires the parties to know which responsibility each holds and to communicate it at the handover. | Normative |
| 4.6 | Communication | Multi-lateral communication at transition points is treated as a control, not as good manners. The draft's text is not public. | Normative |
| 4.7 | Interdependence of safety, effectiveness and security | Safety, effectiveness and security move together: a control that improves one can weaken another, and the document treats the interaction as the theme, not as an exception. | Normative |
| Clause | Row | The answer in one line | Status |
|---|---|---|---|
| 5 | Foundational elements | Eight foundational elements support the themes of Clause 4, each with a statement, a rationale, key concepts and principles, and high-level guidance on an approach. | Normative |
| 5.1 | General | The opening of Clause 5 introduces the eight elements and the four parts each one carries. Its text is not public. | Normative |
| 5.2 | Governance | Governance is the first family: culture, roles and competencies, quality management, information management, and human factors and usability. | Normative |
| 5.2.2 | Organisation culture, roles and competencies | The first foundational element covers the culture that lets people raise a concern, the roles that carry responsibility, and the competencies those roles need. | Normative |
| 5.2.3 | Quality management | The second foundational element covers the quality management system that holds the life cycle processes, their records and their improvement. | Normative |
| 5.2.4 | Information management | The third foundational element covers how health information is managed across its life, including the records that show the system was safe, effective and secure. | Normative |
| 5.2.5 | Human factors and usability | The fourth governance element covers human factors and usability: the design of the work and the interface as they affect safe use. | Normative |
| 5.3 | Knowledge transfer | Knowledge transfer is the second family: risk, safety, security and privacy management, each with communication at the transition points. | Normative |
| 5.3.2 | Risk management | The first knowledge-transfer element covers risk management, including communication at the transition points where risk is transferred. | Normative |
| 5.3.3 | Safety management | The second knowledge-transfer element covers safety management, including the safety information that must cross a transition point. | Normative |
| 5.3.4 | Security management | The third knowledge-transfer element covers security management, including the security information a receiving organisation needs to operate the system. | Normative |
| 5.3.5 | Privacy management | The fourth knowledge-transfer element covers privacy management, including what a receiving organisation needs to protect health information in use. | Normative |
- A. Rationale informative
- B. Concept diagrams informative
- C. Use of assurance cases for knowledge transfer informative
Informative annexes explain and illustrate. They do not create requirements and are never cited as obligations in the register.
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