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cyberacta

Enabling Security & Privacy in Digital Health

Enabling Security & Privacy in Digital Health Enabling Security & Privacy in Digital Health

Artificial Intelligence & Machine Learning in Medical Device

AI refers to the ability of machines to perform tasks that normally require human intelligence – for example, recognizing patterns, learning from experience, drawing conclusions, making predictions, or taking action – whether digitally or as the smart software behind autonomous physical systems 

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.

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SaMD AI Commercialization requires a country by country approach; not one size fits all

SaMD Development and Commercialization Approach. Concept. Input creation. Verification. Usability.

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)

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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“ 

Find out more

CyberActa, Inc.

We have the regulatory savvy, QMS experience, and technical expertise to help mature and emerging technologies companies meet their challenges and take full advantage of their business opportunities.

  • Many technology companies may be unfamiliar with regulatory and SaMD approval processes, and we help, educate, coach them navigate the FDA, and get their products to market. 
  • We advise established pharmaceutical and device manufacturers regarding the development of SaMD practices and procedures regarding global privacy regulations and cybersecurity expectations.
  • We have developed and launched custom and scalable SaMD procedures and SaMD QMS practices:
  • Design controls
  • Risk management 
  • Cybersecurity
  • Human Factors
  • Distribution
  • Purchasing Controls
  • Labeling
  • Privacy
  • Data Integrity
  • Recall

Contact Us

Downloads

Key documentation on Artificial Intelligence and Machine Learning within Medical Device space

European Union approach to artificial-intelligence (pdf)Download
SOUTH KOREA_2017-national-informatization-white-paper (pdf)Download
US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper (pdf)Download

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