Technology and applications
WG II is concerned with standards and specifications in the field of Health Information and Communications Technology (Health ICT), including safety and security aspects, to achieve compatibility and interoperability between independent systems.
The scope includes, but is not limited to, standardization of:
- The application of Health ICT to physical medical devices for plug-and-play interoperability at the point of care and to medical imaging device interoperability;
- Data communication between personal health devices and other systems;
- The data formats used for the exchange of information from medical and other health devices to other systems;
- The production of safe and secure software for health purposes;
- The application of risk management for IT-infrastructure incorporating medical devices;
- The exchange of information with conventional (medical) software for health professionals, the emerging field of health software for consumers, often referred to as mobile health, and the exchange of social care data.
Relationship with WG I
WG II will actively work with others to facilitate its work programme, whenever possible. CEN/TC 251/WG II complements WG I and has a number of common concerns, as well as a set of defined interfaces designed to enable the two groups to work together on given tasks. For some items, expertise from both groups will be required and used as necessary.
The work of others will be appraised and adapted, as necessary, to provide Europe and its member states with the most suitable, interoperability specifications. To facilitate sharing, liaisons and reciprocal exchange of both information and expertise for particular work items will be encouraged.
The following existing groups are expected to be relevant to the CEN/TC 251/WG II work and vice versa:
- Within ISO/TC 215, the Working Groups of interest are:
- WG 2 ‘Systems and Device Interoperability’ (completely);
- JWG 7 ‘Application of risk management to information technology (IT) networks incorporating medical devices’ (completely);
- WG 4 ‘Security, Safety and Privacy’ (joint responsibility with WG I);
- WG 6 ‘Pharmacy and Medicines Business’ (only when referred to WG II by WG I)
- With other SDOs within JIC:
- Other global work/bodies of known interest to WG II:
- IEEE 11073, Continua, and ITU-T/SG 16/eHealth
- On a European level, within the eHealth SDO Platform being formed:
- HL7 Foundation, IHE Europe, ETSI and CENELEC/TC 62
Relevance to European initiatives
- eHealth Network priorities for cross-border care:
- Patient Summaries, ePrescriptions, Patient and Professional Registries;
- Commission policy areas:
- Rare diseases, mHealth, the Active and Assisted Living (AAL) programme and the Active and Healthy Ageing partnership