Medicines and Healthcare Products Regulatory Agency: The Road to Medical Device Reform

The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process. 

Private Equity Investors’ Attitudes Towards Healthcare AI Investment Opportunities

Sidley’s Chad Ehrenkranz and UK-based U.S. investor Chris Yoshida consider which AI-based healthcare applications are of most interest to private equity investors, and the way in which healthcare AI lies in a desirable spot between startups and government uses of AI.

China’s Generative AI Measures Could Affect Life Sciences Companies That Make Apps

Those medtech companies which embed AI into an app allowing healthcare professionals or patients to ask questions and to receive a response will probably need to comply with China’s new Interim Measures for the Management of Generative Artificial Intelligence Services (the “Measures”). Lianying Wang explains.

AI-Powered Drug Discovery Efforts Could Lead to New Treatments

Stephen Abreu, Sidley partner, talks to Colin Hill, CEO and Co-Founder of AI-powered drug discovery company Aitia, about how the use of AI is revolutionizing the biotech space.

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Europe’s Regulatory Approach to Continuous Learning AI

The regulation of continuous learning models involves the challenge of navigating the future. The EU is striving to stay ahead of the game with its forthcoming AI Act and harmonised standards. Eva von Mühlenen, Oliver Haase of Validate, and Leon Doorn of Aidance discuss.

Innovation, Collaboration, and Access to Capital: Key Takeaways from the Sidley Healthcare Investment Conference

At Sidley’s Healthcare Investment Conference on 12 September, speakers analysed the flow of capital across the global life sciences and healthcare ecosystem in panels discussing collaborative deals, sources of funding, the regulatory scrutiny of deals, and women’s health.

Five Governance Steps To Consider When Using Generative AI Within A Pharma Company

Pharma companies are looking to better understand how Generative AI (GAI) can facilitate innovation. Early adopters can gain distinct advantages while properly managing the top-of-mind potential risks discussed below. Francesca Blythe and Steve McInerney explain the corporate governance principles that should be considered.

Five Tips for Bringing a Complex Digital Health Product to Market

Bringing a sophisticated digital health product comprised of a combination of hardware and software to market can be tricky. Meena Datta and Deeona Gaskin advise on how to do so successfully by factoring in FDA marketing and reimbursement pathways, including insurers and employer-sponsored health plans.

The Challenges Facing Artificial Intelligence and Machine Learning Solutions in the FemTech Space

Sidley’s Eva von Mühlenen in Geneva and Josefine Sommer in Brussels talk to oncologist Wolfgang Hackl — the founder of a FemTech startup that guides doctors in the treatment of breast cancer — about regulation, research and development (R&D), and the vast potential of artificial intelligence in the field of health technology for women. (more…)

How Artificial Intelligence Manufacturers Can Protect Themselves Against Future Negligence Claims

Elizabeth Curtin in Chicago and Jonathan Tomlin in London consider why any litigation arising over medtech that uses AI is likely to become complex. They consider how manufacturers of AI can support physicians’ medical judgments and help guard against the danger that they might themselves inadvertently become ‘insurers’ of medical outcomes.

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