TNI CWA 17933
| Name: | TNI CWA 17933 |
| Validity: | Valid |
| Number of pages: | 52 |
| Language: |
EN
|
| Paper: | 21,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
19,26€ b) Without ability to print, with ability to copy (printscreen) 21,40€ c) With ability to print and copy (printscreen) 27,82€ |
| Slovak title | Digitálne a inovatívne zdravotníctvo. Návod na správnu prax pri získavaní súhlasu na použitie osobných zdravotných informácií vo výskume a inováciách |
| English title | Digital health innovations - Good practice guide for obtaining consent for the use of personal health information for research and innovations |
| Release Date: | 01. 09. 2023 |
| Date of withdrawal: | |
| ICS: | 35.240.80 |
| Sorting character/National clasification code | 84 9501 |
| Level of incorporation: | idt CWA 17933:2023 |
| Official Journal | 08/23 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | Since digital health innovations are still under development or within the evaluation process formal consent is usually needed for all stages of the development cycle. This CEN Workshop Agreement (CWA) defines a guideline for devising, obtaining and documenting the most suitable consent for the use of digital health innovations. The guideline describes which aspects should be considered when asking for consent. It specifies the appropriate consent for different situations and how it should be framed and transparently explained. This includes seeking consent for the future reuse of collected data for additional areas of research. The document establishes how to consider ethical and data protection requirements, the wording of consent forms and obtaining ethics committee approval where applicable. |
| Preview: | Náhľad normy (PDF) |