This workshop aims to provide participants with a critical understanding of the significant legal and ethical frameworks governing AI and digital technologies in the healthcare sector. Attendees will explore key legal frameworks such as HIPAA, GDPR, and FDA regulations. The workshop is designed for a diverse audience, including healthcare professionals, legal experts, policy-makers, and AI developers. It examines the implications of AI technologies on patient consent, privacy, and data protection. Participants will engage in discussions on the ethical considerations surrounding AI in diagnosis and treatment, learning to analyse and evaluate these issues using notable case studies that exemplify the intersection of health law and AI. Ultimately, participants will develop strategies for navigating regulatory challenges and promoting interdisciplinary collaboration to advance legal structures that support innovation while safeguarding patient rights.
This workshop is designed to address the profound transformations occurring within healthcare research due to the integration of digital technologies and artificial intelligence (AI). Participants will engage in an in-depth exploration of the evolving responsibilities of Healthcare Institution Review Boards (IRBs) as they adapt to the challenges and opportunities presented by these transformations. Using a multifaceted approach, participants will assess the implications of AI applications on patient rights, data privacy, and ethical standards through interactive sessions, case studies, and expert-led discussions. The concepts of adaptive governance frameworks in responding to rapid advancements in AI and digital health technologies will be explored, aimed at establishing the foundational responsibilities of IRBs in this AI and digital era. Ethical considerations regarding informed consent, biases, fairness, and transparency in algorithms will be examined alongside the legal landscape governing IRB protocols, including GDPR and HIPAA. The workshop is targeted at diverse stakeholders—including clinical researchers, data protection officers, and technology developers—to cultivate a community of practice dedicated to the ethical advancement of healthcare research and enhancing the governance and ethical oversight of IRBs in a digitally enabled landscape.
This workshop provides a thorough exploration of the regulatory frameworks governing the rapidly evolving sector of digital health, focusing on FDA and EMA regulations. Participants will engaged practical selected case studies, such as a mobile health application for diabetics and telemedicine platform, demonstrating the pathways to achieving compliance successfully. Clinical validation and patient safety are critically discussed through the implications of rigorous clinical trials and post-market surveillance, illustrated through a case study of a successful wearable device. Compliance challenges through contrasting case studies with inadequate documentation leading to halted launches, stemming from the absence of proactive engagement (cultural issues) with regulatory authorities
This workshop aims to provide participants with a comprehensive understanding of the legal landscape surrounding telehealth practices. Throughout the workshop, participants will explore critical legal considerations, cross-border regulations, and liability challenges within the telemedicine sector. Legal frameworks affecting telemedicine will be examined through selected compelling case studies addressing issues of patient privacy and data protection. The licensing requirements for physicians, cross-border telehealth services, and the complexities of acquiring multi-jurisdictional licenses will be critically assessed to reinforce understanding of regulatory challenges. Participants will analyse examples of malpractice and liability that illustrate the legal risks faced by telehealth providers, thereby reflecting on the importance of maintaining established standards of care in virtual healthcare interactions. Targeted at multidisciplinary stakeholders, including healthcare practitioners, legal professionals, healthcare administrators, insurance and risk management experts, technology developers, and researchers, participants will engage interactively and collaboratively in group settings. They will explore the future of telehealth law and policies in the context of digital health transformation and artificial intelligence within the evolving regulatory landscape of digital health.
This workshop provides participants with a comprehensive understanding of the intellectual property (IP) landscape pertaining to the rapidly evolving AI and digitally enabled health sector. The workshop equips attendees with the knowledge and strategies necessary to protect their innovations. Participants explore various types of intellectual property rights, including patents, copyrights, trademarks, and trade secrets. Selected case studies will be utilised to illustrate effective IP management, such as Teladoc Health’s strategic use of patents to maintain a competitive edge in telehealth, MyFitnessPal’s copyright registrations to safeguard its software and user interface, and the branding success of “Fitbit” as an example of the crucial role of trademark registration in establishing market presence. Patenting strategies to safeguard innovative diagnostic tools and licensing agreements are discussed, with examples highlighting the importance of defining ownership rights to AI algorithms. Practical exercises, such as drafting preliminary patent applications and navigating problem-solving scenarios related to AI IP challenges, are included.
This workshop aims to provide participants with an advanced understanding of how artificial intelligence (AI) integrates into clinical environments and influences healthcare practices. The workshop critically explores the technical, ethical, and legal dimensions associated with AI in healthcare, addressing the pressing need for healthcare professionals, legal experts, and policymakers to grasp both the transformative potential of these technologies and the inherent risks they present. Participants will engage in an in-depth analysis of AI algorithms’ objectives, algorithmic bias, and the contextualisation of algorithms’ functionality, accountability, and significance in healthcare decision making. The workshop addresses the necessity of ensuring diverse training datasets to yield equitable healthcare solutions. Accountability frameworks in relation to AI applications, which mitigate potential harm from inaccurate recommendations, are discussed. Legal implications are examined through discussions surrounding high-profile cases concerning the liabilities that healthcare providers face when AI systems make errors. The GDPR, which mandates transparency in AI's use of personal data, is reviewed, reflecting the need for compliance with regulatory frameworks in an AI-integrated healthcare ecosystem.