PROJECT SUMMARY Efforts to transform medicine from a reactionary, trial-and-error endeavor to an anticipatory, evidence- based endeavor referred to as “precision medicine” have been underway for several years. Concurrently, efforts also were undertaken to promote patient-centered “learning healthcare systems” (in which scientific research informs the delivery of healthcare and healthcare influences research) and to modernize the applicable ethical, legal, and regulatory frameworks in order to accelerate biomedical innovations. Novel biomedical technologies (including AI-driven robotic surgical technologies, bionic technologies such as the artificial pancreas systems for type 1 diabetes, and bioprinting of organs such as hearts) are advancing rapidly. Yet there are a wide range of ethical, legal, and social implications (ELSI) that remain under-examined and call into question whether existing laws, regulations, and ethical guidelines are adequate for ensuring that these technologies are safe, effective, equitable, and privacy-preserving (while not unethically or unlawfully obstructing patient access to their own health information or hampering the research, development, and realization of the full potential of “mix and match” biomedical technologies tailored to each individual's needs and preferences). In this exploratory project, we seek to examine the data practices, data privacy, data access, and data justice issues (Aim 1); examine regulatory pathways and identify regulatory gaps (Aim 2); and examine liability risks (Aim 3) related to the development and use of three technologies in healthcare: robotics, bionics, and bioprinting. To do so, we will rely upon an innovative combination of bioethical, legal, and anthropological approaches involving key informant interviews with scientists/engineers and lawyers, internet research of technology developers' website disclosures, normative bioethics and comparative legal research (comparing the US and EU regulatory frameworks), and legal research of emerging case law in four areas: products liability, medical malpractice liability, organizational liability, and intellectual property infringement. This approach could identify similarities and differences among the three technologies and also identify gaps in perceived and actual liability risks. The successful completion of this project would provide important insights that would not only lay a solid empirical foundation for subsequent empirical and normative ethical, legal, and social implications (ELSI) research regarding robotics, bionics, and bioprinting but also provide important insights to inform the development, and refinement of educational materials, engineering standards, research and clinical practice guidance, and institutional and public policies and procedures to help ensure the technologies' ethical and responsible use in precision medicine.

PROJECT NARRATIVE Innovative biomedical engineering technologies offer considerable promise for improving the health of individuals and are developing rapidly to address a wide range of medical conditions and circumstances. A proactive approach that addresses ethical, legal, and anthropological considerations upfront as part of the design process is critical to ensure the technologies are privacy-preserving, safe, effective, and equitable. This exploratory project seeks to clarify pressing ethical, legal, and social implications of three emerging technologies (i.e., robotics, bionics, and bioprinting) to enable biomedical engineers, healthcare professionals, and policymakers to ensure their ethical and responsible use in precision medicine.