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

CQC rating more healthcare services including Babylon Health

SGS - certify healtcare software new HSP Safety Mark

Areas of regulation

Technical product assessment

International standards based criteria and methodology

Testing by qualified experts

Benchmarked references

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)

NICE

HTA assessment in 2017??

DAQ

Output:Apps library

eHealth Innovation

Digital therapies - IAPT

NHS apps library

US (user testing)

mhabitat