Evaluation of SaMD that delivers Ttmely care to patients

Committee:
Medical Equipment
status:
New
Published:
Premium-based evaluation of SaMD that contributes to reducing the working hours of healthcare professionals was not adopted in the FY2026 revision. A mechanism remains necessary to evaluate the patient benefit where reduced working time leads to shorter waiting times for tests and treatment or to the provision of necessary care.

Recommendations

  • Consider evaluation through a premium where reduced working hours are shown to deliver patient benefits, such as shorter waiting times for tests and treatment.
  • Use intermediate indicators, such as time to treatment initiation, in evaluations, taking into account their relationship to final clinical outcomes.
  • For radiotherapy planning support and similar applications, verify not only the impact on working time but also on the timeliness and safety of care delivered to patients and on care delivery capacity.
  • Where safety and quality of care can be ensured, also proceed with reviewing facility standards and billing requirements.