During Prime Minister Rishi Sunak's recent visit to Washington D.C., as he announced that the U.K. would host the first global summit on AI regulation later this year, he bristled in response to a reporter's question about whether the "midsize country" could naturally lead the debate, given that the E.U. is close to passing a landmark AI bill. "That midsize country happens to be a global leader in AI," he said. "You would be hard-pressed to find many other countries other than the U.S. in the Western world with more expertise and talent in AI." The Prime Minister's response revealed the dilemma he now faces in positioning the U.K. as a key player in reining in AI's potential negative consequences without stifling innovation, amid growing fears around generative artificial intelligence. Following the U.K.'s departure from the European Union, experts say Sunak is attempting to carve out a pivotal role to help keep the country globally relevant by playing the role of an "honest broker" between the different regulatory approaches of the E.U. and the U.S. when it comes to AI.

The regulatory approach towards artificial intelligence is currently the subject of heated debate among policy makers. This regulatory debate is, however, dominated by a one-dimensional viewpoint, in which the digital forest cannot always be seen for its trees. Contrary to popular belief, however, artificial intelligence does not in and of itself constitute a regulatory problem. Artificial intelligence (AI) is not a new phenomenon. Various AI applications, such as machine vision, have been in use in Finland for several decades.

The British approach to regulation focuses on high-risk applications, setting aside low risks associated with AI so that innovation will not be hampered, and the industry not burdened with red tape. Unlike the EU approach, where the enforcement of the AI Act will be handed down to a single national regulator for each member state, the UK is planning to give responsibility to a range of them. The principles laid out in the British approach "provide clear steers for regulators, but will not necessarily translate into mandatory obligations", the policy statement warns, encouraging them to "consider lighter touch options in the first instance" instead. London recognises the "inherent cross-border nature of the digital ecosystem" and stresses the need to work "closely with partners" to avoid fragmenting the global market, "ensure interoperability and promote the responsible development of AI internationally". Stakeholders in the AI ecosystem are invited to share their views by the end of September about this regulatory approach to inform a forthcoming White Paper on the implementation of such a strategy.

Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as a medical device, cybersecurity, medical device interoperability, wireless medical devices, mobile medical apps and telemedicine. To meet this goal, Health Canada established the Digital Health Division under the Medical Devices Bureau and has been increasing its efforts to build in-house expertise. On October 27, 2021, Health Canada, the US Food and Drug Administration (FDA), and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) jointly published the Good Machine Learning Practice for Medical Device Development: Guiding Principles. The document consists of 10 guiding principles to help promote safe, effective, and high-quality use of artificial intelligence and machine learning (AI/ML) in medical devices.

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, on Thursday called out the need for better methodologies for identification and improvement of algorithms prone to mirroring "systemic biases" in the healthcare system and the data used to train artificial intelligence and machine learning-based devices, speaking at an FDA public workshop on the topic. The medical device industry should develop a strategy to enroll racially and ethnically diverse populations in clinical trials. "It's essential that the data used to train [these] devices represent the intended patient population with regards to age, gender, sex, race and ethnicity," Shuren said. The virtual workshop comes nine months after the agency released an action plan for establishing a regulatory approach to AI/ML-based Software as a Medical Device (SaMD). Among the five actions laid out in the plan, FDA intends to foster a patient-centered approach that includes device transparency for users.

With the withdrawal of the U.K. from the European Union, MHRA as part of its new Brexit freedoms is moving to update the country's regulations for software and AI as a medical device without the burden of accommodating the regulatory approaches of EU members. "These measures demonstrate the U.K.'s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes," states MHRA's announcement. "Regulatory measures will be updated to further protect patient safety and take account of these technological advances." AI and SaMD technologies have the potential for better diagnosing and treating a wide variety of diseases, but FDA has yet to finalize a regulatory framework for machine learning-based software as a medical device. The agency is considering a total product lifecycle-based regulatory framework for adaptive or continuously learning algorithms.

U.S. Chief Technology Officer Michael Kratsios and Energy Secretary Dan Brouillette shed a little light on how the Energy Department and Trump administration are thinking about ethics, regulatory approaches, and broader societal implications as they push the rollout of artificial intelligence and other emerging technologies. During a fireside chat in Pittsburgh Tuesday, Brouillette reflected on similar-but-as-serious considerations previously made when the agency was developing nuclear technologies many years ago. He noted that now, when focusing on ethics, his mind tends to hone in on negative aspects and "bad results" that could arise with tech adoption. "I haven't thought this through with great depth, but there seems to be some positive aspects of AI, too, on the ethics front that we need to explore," Brouillette told the chat's moderator Carnegie Mellon University Vice President of Research Michael McQuade. "And perhaps through that process we can speed the adoption of some of these technologies," he said, adding that he'd like to give it all more thought.

First, the two cumulative criteria proposed by the Commission will inevitably be incomplete, leaving some applications out. That's the tradeoff for simple rules – they miss the mark in a small but significant number of cases. To work properly, simple rules must be supplemented by a general catch-all category for other high-risk applications that would not qualify under the two-criteria test. If you add a catch-all test (which would be necessary in our view), the goal of legal certainty would be largely defeated. Second, the "high risk" criterion will interfere with other legal concepts and thresholds that already apply to AI applications.

It took a global pandemic and stay-at-home orders for 1.5 billion people worldwide, but something is finally occurring to us: The future we thought we expected may not be the one we get. We know that things will change; how they'll change is a mystery. To envision a future altered by coronavirus, Quartz asked dozens of experts for their best predictions on how the world will be different in five years. Below is an answer from Zia Khan, the senior vice president of innovation at The Rockefeller Foundation, a private foundation that seeks to promote humanity's wellbeing. Many of his professional experiences--as a management consultant, serving on the World Economic Forum Advisory Council for Social Innovation--have helped show him how to use data and technology to positively transform people's lives.

As digital health innovation has outpaced the FDA's regulatory structure, the agency's top official wants to overhaul the approval process for new technology. That overhaul comes by way of a new Medical Device User Fee Agreement (MDUFA) that is making its way through Congress despite some recent pushback from Department of Health and Human Services Secretary Tom Price. A portion of the four-year agreement includes the creation of a central digital health unit within the FDA's Center for Devices and Radiological Health. RELATED: Tom Price revisits Trump's proposal to double FDA user fees Although that agreement wouldn't take effect until October, Bakul Patel, associate director for digital health, told Wired that he's already begun hiring key positions for the new department that will eventually include 13 engineers. Once he has a team in place, Patel wants to restructure the FDA's approach to digital health entirely, making it easier for new solutions and technology to get to market faster.