| Article | Update description | Date | User group |
|---|---|---|---|
| Cyber security and resilience for digital healthcare technologies | A new content piece has been added to provide developers of digital technologies with guidance on the cyber security and resilience of devices, services and networks. | April 18 | Developers |
| Cyber security and resilience for health or care services | A new content piece has been added to provide adopters deploying digital technologies with guidance on the cyber security and resilience of devices, services and networks. | April 18 | Adopters |
What's new
Find out what changes have been made to the AI and Digital Regulations Service.
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Found 11 articles.
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| Article | Update description | Date | User group |
|---|---|---|---|
| Data quality considerations for training and testing | This page has been updated to include STANDING Together’s Recommendations for diversity, inclusivity, and generalisability in artificial intelligence health technologies and health datasets. | November 6 | Developers |
| Is your technology a medical device? | New content piece added to support developers in determining if their technology is a medical device. | November 6 | Developers |
| Planning for evidence generation | This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market, and on MHRA's AI-Airlock which will be launched in April 2024. | November 6 | Developers |
| Understanding routes to NICE health technology assessment | This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market. | November 2 | Developers |
| Generating evidence for NICE health technology assessment | This page has been updated to provide information on NICE Advice, which supports healthtech companies seeking to enter the NHS market. | November 2 | Developers |
| Understanding routes to NICE health technology assessment | This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market. | November 2 | Developers |
| Determining the intended purpose of your software medical device | The MHRA has published new guidance on crafting an intended purpose in the context of Software as a Medical Device. The content on our website has been updated to reflect the new guidance. | July 14 | Developers |
| Post-market surveillance of medical devices | The MHRA has published new guidance on reporting adverse incidents involving Software as a Medical Device under the vigilance system. The content on our website has been updated to reflect the new guidance. | July 14 | Developers |
| Thinking about whether a medical device will meet your needs | New guidance added on how to assess whether a medical device will meet your needs. | June 7 | Adopters |