This week, the European Commission unveiled new proposed rules “aiming to turn Europe into the global hub for trustworthy” artificial intelligence. The 108-page first-of-its-kind policy outlines how companies and governments should use artificial intelligence, and sets “limits around the use of artificial intelligence in a range of activities, from self-driving cars to hiring decisions, bank lending, school enrollment selections and the scoring of exams.” Importantly, the proposed rules also directly impact artificial intelligence application in robot-assisted surgery.

The rules follow a risk-based approach, where artificial intelligence systems are placed into one of four categories: unacceptable risk, high-risk, limited risk, and minimal risk. Those classified as high-risk include artificial intelligence used in “safety components of products.” According to the Commission, this category encompasses “AI application in robot-assisted surgery.” High-risk systems will be subject to strict obligations, which include:

  • Adequate risk assessment and mitigation systems;
  • High quality of the datasets feeding the system to minimize risks and discriminatory outcomes;
  • Logging of activity to ensure traceability of results;
  • Detailed documentation providing all information necessary on the system and its purpose for authorities to assess its compliance;
  • Clear and adequate information to the user;
  • Appropriate human oversight measures to minimize risk; and
  • High level of robustness, security and accuracy

Before they take effect, the proposed rules will need to be adopted by the European Parliament and its Member States.

As was noted in a recent NY Times Article, “[f]or years, the European Union has been the world’s most aggressive watchdog of the technology industry, with other nations often using its policies as blueprints.” But now, “President Biden has filled his administration with industry critics,” and new rules directly impacting the use of artificial intelligence are also being considered by United States government authorities. How such new rules will impact the robot-assisted surgery industry remains to be seen. Yet one thing is certain.  Changes are coming.  And it will be important for companies to adopt policies and procedures that embrace these changes, and retain experienced legal counsel to identify, assess, and mitigate future risks.