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Regulation of digital tools (Areas of regulation (Technical product…
Regulation of digital tools
Medicines & Healthcare products Regulatory Agency
Software as Medical Device (SaMD). Likely to be software if: it is linked to a specific medical device, intended to influence the actual treatment, results in a diagnosis
Medical device given a cite mark (safety, health and environment)
Based on EU guidelines
Regulatory bodies
SGS
- certify healtcare software new HSP Safety Mark
products currently regulated under general consumer product safety regulations (GPSD-CPSA)
mHealth
mandate to develop guidelines for assessing the validity and reliability of data (no consensus reached)
CQC rating more healthcare services including Babylon Health
Areas of regulation
Technical product assessment
International standards based criteria and methodology
Testing by qualified experts
Benchmarked references
NICE
HTA assessment in 2017??
DAQ
Output:
Apps library
eHealth Innovation
US (user testing)
Digital therapies - IAPT
NHS apps library
mhabitat