Background Information
AI & ML in Medical Devices
As of right now, there is no globally recognized standard regarding AI & ML in Medical Devices of Healthcare.
There are multiple working groups, developing standards for all industries: Foundational standards (terminology, framework); Big Data (vocabulary, reference architecture); Trustworthiness (risk, robustness, bias); Use cases & applications; AI Governance.
Development & Commercialization
Additional Information
Whether using a predictive (Waterfall; V- model) or adaptive methodology (Agile), it is imperative that the following processes and their corresponding outputs to be incorporated in the SaMD Development:
- Software development planning (SDP)
- Requirements analysis
- SaMD architectural design
- Software unit implementation and verification
- Software integration and integration testing
- SaMD verification and validation
- Problem resolution
- Configuration management
- SaMD release & maintenance
- SaMD Design Traceability
- Risk Management Activities
SaMD is still a medical device
Manufacturers of SaMD must report any correction or removal of an SaMD if action was initiated to:
- Reduce a risk to health posed by the device, or
- Remedy a violation of the FDCA caused by the device which may present a risk to health
- Report must be submitted within 10 working days of initiating the correction or removal
- FDA interprets “initiating” the correction or removal as the date a firm makes the decision to initiate a field action (62 FR 27188)
Recent Developments on SaMD AI/ML in Europe
Additional Information
The European Commission put forward a European approach to Artificial Intelligence and Robotics. It deals with technological, ethical, legal, and socio-economic aspects to boost the EU's research and industrial capacity and to put AI at the service of European citizens and the economy.
The European Commission published a White Paper aiming to foster a European ecosystem of excellence and trust in AI and a Report on the safety and liability aspects of AI. The White Paper proposes:
- Measures that will streamline research, foster collaboration between the Member States and increase investment into AI development and deployment;
- Policy options for a future EU regulatory framework that would determine the types of legal requirements that would apply to relevant actors, with a particular focus on high-risk applications.
ARTIFICIAL INTELLIGENCE IN EU MEDICAL DEVICE LEGISLATION
The European Trade Association COCIR posted their position paper regarding AI in healthcare.
Also, you may want to review Knowledge Centre Data & Society (2020) “Feedback on EC White Paper on Artificial Intelligence“