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Freshfields MedTech Update Q1 2024

AI advancements in MedTech continue to play a prominent role in transforming the healthcare industry through innovative care and improved patient outcomes. At the same time, global regulators and policymakers are stepping up efforts to regulate the development and use of AI technology in healthcare and beyond.

On March 13, 2024, the European Union approved the AI Act, the world’s first comprehensive AI regulation. We expect MedTech industry leaders and regulators alike to continue to remain focused on the integration of AI into healthcare offerings as they navigate a growing patchwork of laws, regulations and guidance with respect to data, antitrust and intellectual property implications.

First AI/ML Initiative Accepted into the FDA’s ISTAND Pilot Program to Advance Drug Development

Deliberate AI’s assessment tool for anxiety and depression, the AI-generated Clinical Outcome Assessment or AI-COA™, will receive support to become a qualified drug development tool (DDT) through Innovative Science and Technology Approaches for New Drugs (ISTAND), an FDA pilot program. The ISTAND program was designed to create a new pathway for FDA to provide support for unconventional drug development tools, including tools that implement AI algorithms, wearables, and other digital health technologies. AI-COA™ leverages multimodal behavorial signal processing and machine learning technology to record mental health symptoms and assess the severity of anxiety and depression cases. FDA’s inclusion of this assessment tool in the ISTAND program signifies the agency’s commitment to fostering innovation in drug development and evaluation, particularly in the field of mental health. We expect FDA engagement in this space to pave the way for increased use of AI to enhance mental health therapy at scale as MedTech companies are encouraged to explore innovative approaches to effective mental health therapy.

Cyberattack on the Largest U.S. Health Care Payment System

Change Healthcare, a subsidiary of UnitedHealth and the nation’s largest processor of medical claims, was recently hit with ransomware attack, disrupting its nationwide healthcare systems and threatening the security of patients’ information. In response to the hack, the company has shut down most of its network to prevent further impact, though some critical services were reportedly restored by mid-March. The company is currently working with cybersecurity firms to fully restore its data and systems. The U.S. Department of Health and Human Office for Civil Rights began an investigation into the cybersecurity incident focusing on Change Healthcare’s compliance with HIPAA regulations and assessing whether a breach of protected health information occurred. As the MedTech industry continues to collect, store and transmit increasing amounts of sensitive patient health information, companies operating in the space should prioritize the development and implementation of a tactical and comprehensive plan to prepare for and mitigate damages arising from cyber incidents.

42nd J.P. Morgan Healthcare Conference

The 42nd J.P. Morgan Healthcare Conference brought together thousands of professionals in the biopharma, biotech, and MedTech industries, setting the stage for new partnerships and exciting product launches. AI was a major topic of discussion, with tech and life sciences companies coming together to develop AI tools for drug discovery and development as AI proves its value in target identification, clinical trial design, and more. In the digital health space, tools developed for diabetes management, including continuous glucose monitoring devices and virtual speciality care services, received considerable attention. Increasing numbers of health-monitoring partnerships between companies like Amazon and Omada aim to introduce virtual care benefits for individuals with chronic conditions, such as diabetes and hypertension. In addition to these collaborations, a number of MedTech acquisitions were announced, including Veracyte’s acquisition of C2i Genomics and its cancer-detecting technology, and GE HealthCare’s acquisition of medical imaging company MIM Software. The exciting therapeutic developments, along with the surge in M&A activity, provided a sense of optimism for a dynamic and successful 2024 for the MedTech sector.