Digital standards scope extended
Apps and software that are not medical devices, but could influence patient care pathways, or integrate into NHS systems must comply with NHS Digital standards SCCI 0129/0160. A key feature is oversight of risk management by a practising healthcare professional acting as a “Clinical Safety Officer”.
As of July 2018, the scope of the standards extended to include digital medical devices. Both “manufacturers” and NHS organisations adopting digital solutions face significant new skills, know-how and documentation requirements.
Assessing compliance implications early in a development helps verify digital project viability, plan and deliver the optimum solution. Lucid can help, contact us.