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Clifford Chance

Clifford Chance

Healthtech Trends 2024

Five trends to watch

From medical microrobots to patient digital twins to generative AI for the creation of synthetic health data, we take a look at the next wave of tech innovations creating opportunities and challenges for healthcare and life sciences in 2024 and beyond.

Gunnar Sachs, Partner, Co-Chair of the Clifford Chance Healthtech Group, says...

"In hardly any other industry is digitalisation progressing as fast and are new digital innovations facing such strict regulation as in the healthcare sector. Technically, a lot is possible today, starting with the use of AI in clinical research to remote-controlled cross-border high-precision interventions to scaling artificial (synthetic) health data and digital patient twins. However, all these new technologies still face considerable legal challenges in nearly all jurisdictions globally. Innovators are therefore constantly required to keep abreast of all new legal developments in the fast-developing health-tech space."

Stephen Reese, Partner, Co-Chair of the Clifford Chance Healthtech Group, says...

"As AI, robotics, and uses of big (health) data continue to advance, new opportunities are emerging in healthcare delivery, personalised medicine and medical research. With this comes a need to navigate new digital regulations and other legal requirements beyond those specific to healthcare and life sciences. Strategic management of risk and protection of rights will also be key, particularly in relation to data and IP. "

Christine Kim, Associate in the Clifford Chance Healthtech Group, says...

"In the past the most advanced technological developments in the life sciences were often limited to more exclusive (and usually more expensive) uses. Today they are increasingly found in more common, accessible settings. This article highlights the next generation of digital health and healthtech, and as we explore its perils we also consider its promise to put us on a possible path to health equity. Given the pace of innovation, that path now looks closer than we've seen before." 

What's ahead for 2024?

Advances in AI/ML and machine perception are supporting the rise of next generation medical robots

In Healthtech Trends 2023 we explored how medical robotics are moving remote healthcare treatment from concept to reality. For years, robotic assistance has been transforming healthcare provision in other areas too: surgical-assistance robots are becoming capable of more complex and precise procedures, rehabilitation robots are supporting therapy, and other robots are monitoring and transporting patients, dispensing medicine and disinfecting equipment. Now, medical robotics is advancing further as AI/ML and machine perception are progressing and innovations to overcome technical challenges are being engineered.

What's next?

With the increasing integration of AI/ML, IoT technologies, data analytics and machine perception robotics across a range of healthcare use cases is expected to reach higher levels of precision, accuracy, and autonomy and to have the capacity to react and adjust performance in real-time. In some cases—such as medical microrobots in the body—microscopic technologies have the potential to yield massive results.

These technologies will continue to face regulatory and other legal hurdles in addition to traditional requirements for the provision of medical care. These include navigating obligations under medical device regulations, product liability regimes, new AI-related rules, and data and cyber laws.

Marie-Caroline Buiatti, Associate, says...

"We are seeing an increasing number of healthcare actors – from public and private hospitals to medical device companies – investing in the acquisition or development of medical robotics, which should enable the MedTech environment to grow. By allowing medical staff to focus on direct patient care, next generation robotics will allow a greater number of patients to be treated – with a particularly positive impact in countries with growing patient populations. The importance and sophistication of medical robotics is such that the question now arises: will these tools begin to replace physicians in certain instances?"

Technology is continuing to help democratise healthcare

The pandemic supercharged the proliferation of telehealth, telemedicine, and other remote health-monitoring solutions in many jurisdictions and, with this, discussions on broadening access to health data. However, despite services being increasingly digitalised and patients being empowered to actively manage their health, healthcare systems remain strained with providers continuing to confront the challenges of aging or expanding populations, staff shortages and burnout, inefficient processes, and access limitations.

What's next?

New requirements and guidance from regulatory authorities relating to access to healthcare services and clinical trials are providing an opportunity to tackle these issues and perhaps to also combat health inequities.

Digital solutions are expected to continue supporting greater efficiencies in the provision of care in hospitals. AI-enabled digital assistants will provide greater efficiencies by helping to manage administrative tasks and by optimising waiting lists and resources. Digital wards will alleviate some impacts of staff shortages by facilitating automated point-of care observation capture, real-time tracking of patient results and staff alerts for scheduled tasks.

With a continuing shift to decentralised healthcare, including higher quality care at home, some providers are turning to healthcare-as-a-service (HaaS) and monitoring-as-a-service (MaaS) models to bring together connected devices and IoT infrastructure for more integrated data and clinical workflows. The EU Data Act includes rights and obligations designed to increase the accessibility of data generated by connected products, creating both challenges and opportunities for providers of IoT-connected medical devices and health wearables and for other participants who could use that data to provide services to the users of such connected products.

Andrea Andolina, Senior Associate, says...

"Post-pandemic, several jurisdictions are becoming increasingly aware of the critical role of technology in healthcare, catalysing a shift towards telemedicine, digital diagnostics, and AI-driven predictive analytics. There is a move to decentralised and home-based treatments, which makes healthcare more sustainable and accessible to a broader (and often ageing) population. Data, AI and technology are the enabling factors of this movement."

Patient digital twins will advance personalised medicine

Precision medicine is continuing to make use of multiomic data to improve predictive accuracy and ultimately to improve diagnoses and targeted treatment. Efforts are also continuing to integrate multimodal patient and population data with updates in real time on both the patient and the environment. Advancements in processing, integrating, and applying data are bringing us closer to the ultimate form of personalised care: digital twins (virtual representations) of patients. Patient digital twins can provide powerful predictive capabilities for both emergency response and preventive care through real-time monitoring.

What's next?

Digital twin technology for personalised medicine is expected to develop in the form of digital biological systems that model and monitor conditions in a more targeted way. Even without a "full" patient digital twin, genomic data and large volumes of digitised personal health data combined with AI, provide the tools for increasingly personalised treatments. Projects and partnerships that unlock health data and genomic data pooling will be an area of focus and investment. In collaborations involving data pooling, parties will focus on precisely defining the permitted uses of data and the ownership and licensing of IP to protect their respective commercial interests.

Digital twins are also expected to significantly assist with clinical trials—for example, by increasing control and test group size by forecasting clinical outcomes of a subset of clinical trial participants.

Emma Davies, Partner, says...

"Personalised medicine is the new frontier in healthcare. Digital twins and other technologies are helping to unlock health data and genomic data for improved diagnostics, targeted drugs and tailored treatments. Strategic contracting and early consideration of regulatory requirements will be important for successful projects and partnerships in this space."

Laura de Arroyo Garcia, Associate, says...

"Digital twins have the potential to transform population health management by informing resource allocation, public health strategies and evidence-based policies, and directing interventions that promote better health outcomes at community level. Their successful deployment will require a multidisciplinary and multipractice approach, as well as rigorous mapping of end-to-end legal and ethical risks, from privacy issues around data overcollection and downstream use, to analytics biases, technology accessibility and democratisation considerations."

Breaking down data silos will be key for value-based care and ominichannel care

Health data access and use is being pursued by businesses and promoted by governments in various parts of the world to help generate new products and services and to stimulate competitive markets. In some jurisdictions, omnichannel patient interactions – where multiple service providers across a patient's journey operate together via the exchange of information across platforms – are growing in popularity as a means of improving the patient experience. In other jurisdictions, there is a continuing shift toward value-based healthcare with a data-fuelled, holistic view of patient populations to pay doctors based on the level of positive impact achieved for patients.

What's next?

Healthcare providers, life sciences companies and medical organisations are accustomed to being required to maintain tight controls on sharing health data. However, navigating these rules will become more complicated. Privacy laws continue to proliferate and diverge globally – including, in some cases, requirements specific to health data – and we expect more data privacy and security laws to sit alongside laws that seek to facilitate, or even mandate, certain types of health data sharing and access.

In the EU, the Data Governance Act and Data Act made groundbreaking changes in this direction, and attention is now focused on the provisional agreement by the Council of the EU and the European Parliament for a European Health Data Space, which sets out rules, common standards and practices as well as infrastructure and governance frameworks to empower individuals through increased digital access to, and control of, their electronic personal health data. It aims to support the free movement of health data, as well as secondary use for research, innovation, policy-making and regulatory activities.

Violetta Kokolus, Partner, says...

"The healthcare ecosystem is evolving, with entrants experienced in tech, retail and other sectors bringing new approaches and traditional players diversifying their businesses. Collaborations combining different areas of expertise are developing innovative products and services. Greater health data access holds huge potential for catalysing new discoveries, technologies and operating models in this dynamic environment: we can expect greater focus on responsible data sharing and transparency from governments, regulators and public and private organizations."

Diversifying AI use is supporting innovation and efficiency

For many years, AI/ML have been making drug discovery, development, trial and assessment more efficient and accurate. We are now seeing an emerging role for generative AI (GenAI) in accelerating de novo drug design to identify drug candidates. The creation of synthetic datasets with GenAI is also unlocking medical research that might have otherwise stalled due to privacy restrictions or other limitations on data availability. GenAI has also been assisting with medical diagnostics in healthcare settings, in some cases achieving accuracies that are on a par with, or even better than, medical professionals.

What's next?

AI-specific laws will continue to emerge, following notable developments such as the EU AI Act and the US framework for AI with President Biden's Executive Order calling for AI regulation in "critical" fields such as healthcare. The interplay between AI-specific laws, AI-relevant laws and other, related frameworks that already exist – such as privacy requirements and medical device regulations – will require careful consideration for the significant number of medical devices, apps and platforms that will leverage AI-based systems.

While greater certainty around regulatory positions and acceptable safeguards for AI will help improve acceptance of AI tools in healthcare and the life sciences over time, legacy agreements with service providers that rely heavily on the use of AI will need to be reviewed. Many large business-process-as-a-service (BpaaS) outsourcing arrangements will not have envisaged the use of generative AI and new market conditions and will need to be revisited to address gaps and attendant risks. Read our briefing: AI in US Healthcare Outsourcing – It's Time to Check Your Contracts

Yi Yang, Partner, says...

"AI is transforming healthcare and life sciences, enabling new discoveries, improved diagnostics, efficiency enhancements and personalised treatments. As the legal landscape for AI evolves, organisations will increasingly need to address issues such as human oversight, accountability, fairness and transparency in their AI strategies. We can expect a continued focus on AI in transactions, investments and collaborations – as well as sustained regulatory attention in this area."

Meet our Healthtech team

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Gunnar Sachs

Gunnar Sachs

Partner
Düsseldorf

+4921143555460

Gunnar

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Gunnar Sachs specialises in intellectual property law, with long-standing experience in the healthcare, chemicals and consumer goods sectors.

Beyond regulatory advice, he works on strategic M&A and private equity transactions, corporate reorganisations, complex litigation and commercial projects as well compliance audits. Above all, he has particular expertise in digital topics as well as IT-based business models and advises clients across all sectors on digital transformation and data protection.

Stephen Reese

Stephen Reese

Partner, Co-Head of the Healthcare & Life Sciences Sector
London

+442070062810

Stephen

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Stephen Reese is an experienced IP specialist advising clients on both contentious and non-contentious aspects of intellectual property rights. He advises broadly on strategy and the protection, exploitation and enforcement of intellectual property rights, including patents, trademarks, designs, trade secrets and copyright. He is a core member of our Global Healthcare & Life Sciences Sector Group.

Stephen has significant experience advising clients within the life sciences, healthcare, technology and FMCG sectors. He also advises on the UK and EU regulatory aspects of pharmaceuticals, biologics and medical devices and their interaction with IP strategy, exploitation and enforcement.

Christine Kim

Christine Kim

Associate
New York

+12128788272

Christine

Christine Kim advises privately and publicly held companies, both targets and acquirors, in cross-border and US transactions and corporate matters. Her experience spans a broad range of sectors and industries, as well as a diverse variety of matters, including mergers, acquisitions, divestitures, carve-outs, spin-offs, joint ventures, and strategic investments.

Leigh Oliver (She/Her)

Leigh Oliver (She/Her)

Partner, Co-Head of the Healthcare and Life Sciences Sector and Head of US Antitrust Practice
Washington D.C.

+12029125933

Leigh

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Leigh Oliver is Head of the US Antitrust Practice, Co-Head of the Healthcare & Life Sciences Sector and specializes in antitrust issues ranging from bet-the-company merger control matters to state and federal antitrust investigations. She has two decades of experience advising clients in heavily scrutinized industries, including healthcare, life sciences, aerospace and defense and industrials. She regularly represents clients before federal and state antitrust agencies and in merger litigation in federal court.

Yi Yang

Yi Yang

Partner
Shanghai

+862123207201

Yi

Yi Yang has over 15 years’ experience in advising multinational and Chinese companies on cross-border mergers & acquisitions, joint ventures, disposals and strategic alliances across a wide range of sectors, including healthcare & life sciences, consumer goods & retail, real estate and manufacturing.

Violetta Kokolus

Violetta Kokolus

Partner
New York

+1 (212) 878 3291

Violetta

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Violetta Kokolus possesses 15+ years of experience working with emerging and established companies and technology-focused investors, particularly within the fields of asset management, payments, consumer products, data innovation, healthcare, tech-enabled services, robotics and software. Violetta advises on tech aspects of mergers and acquisitions and also represents companies in stand-alone collaborations and strategic commercial transactions with complex technical and intellectual property considerations.

Emma Davies

Emma Davies

Partner
Hong Kong

+85228258828

Emma

Emma Davies heads Clifford Chance's Asia Pacific Healthcare & Life Sciences Sector Group. She has 25 years of experience advising clients on M&A, private equity and corporate restructuring matters. In addition, she led the China Corporate/M&A group in Shanghai from 2002–2012 and founded the Firm’s China antitrust practice. Emma is fluent in Mandarin Chinese.

Emma is ranked as a Leading Lawyer for Life Sciences and Corporate/M&A by Chambers Asia Pacific.

Claudia Milbradt

Claudia Milbradt

Partner
Düsseldorf

+4921143555962

Claudia

Claudia Milbradt specialises in IP and Tech matters and is a member of Clifford Chance's global Tech group.

She is very experienced in patent and other IP litigation (preliminary injunction proceedings, action on the merits, nullity actions, invalidity proceedings) and strategic advice for crossborder IP litigations.

Claudia has significant experience in technology transfer, patent license agreements as well as research and development projects.

Claudia also supervises IP teams in the acquisition of technology companies and advises clients in complex technology driven transactions.

Ling Ho

Ling Ho

Partner
Hong Kong

+85228263479

Ling

Ling Ho has spent over 30 years advising clients on intellectual property related matters in the Greater China region. Her expertise covers the full spread of contentious and non-contentious IP issues. She is the head of the Hong Kong Litigation and Dispute Resolution practice and is a core member of the firm's global Tech Group with particular focus on IP, cyber, tech disputes and risk management.

Ling has extensive trial, deal and strategic counselling experience, and has acted in leading cases in the fields of trademarks, patents, copyright, designs to confidential information.

Ling is regularly involved in negotiating and drafting brand usage, technology transfer and other IP related collaboration agreements for clients investing into Asia markets.

Ling's practice also spans arbitration, commercial litigation, cyber, data privacy, defamation as well as product liability claims. Her clients range from multinational corporations and government agencies to leading businesses and individuals in the region, across a broad spectrum of industries including healthcare, technology, media, consumer goods and retail, financial services and leisure.

Meighan O'Reardon

Meighan O'Reardon

Partner
Washington D.C.

+12029125502

Meighan

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Meighan O’Reardon leads the US Tech//Digital team at Clifford Chance. Her practice focuses on negotiating and managing complex services and technology deals across multiple industries, most notably in the financial services, healthcare and manufacturing sectors. Meighan is regularly called upon to lead third party contracting work associated with large corporate transactions including in connection with IT and business process Transition Service Agreements and post-deal operations integration. She regularly supports transformational initiatives at her clients as they procure new services and technologies to improve efficiency, reduce costs and implement new technology solutions.

Torsten Syrbe

Torsten Syrbe

Partner, Co-Head of the Healthcare & Life Sciences Sector
Düsseldorf

+4921143555120

Torsten

Torsten Syrbe advises major international corporations on their global operations. He specialises in the global healthcare and life sciences sector, while also regularly advising clients in the tech space, private equity and various other industries. He is a core member of our Global Healthcare & Life Sciences Sector Group.

Torsten started his career at Clifford Chance's Brussels office and subsequently worked in the Düsseldorf office prior to relocating to Moscow in 2002. Following two decades based in the Moscow office, where Torsten led dozens of headline M&A transactions across the region, precedent antitrust cases as well as prominent compliance investigations and regulatory projects, he moved back to Düsseldorf in May 2022.

Torsten continues his practice out of Germany, steering complex, high-end projects across Europe and beyond. Over the past 20 years, Torsten has frequently been highly ranked in the international directories for his antitrust and healthcare expertise.

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