Artificial Intelligence and Liability in Medicine: Balancing Safety and Innovation.

Policy Points With increasing integration of artificial intelligence and machine learning in medicine, there are concerns that algorithm inaccuracy could lead to patient injury and medical liability. While prior work has focused on medical malpractice, the artificial intelligence ecosystem consists of multiple stakeholders beyond clinicians. Current liability frameworks are inadequate to encourage both safe clinical implementation and disruptive innovation of artificial intelligence.

The need for health AI ethics in medical school education.

Health Artificial Intelligence (AI) has the potential to improve health care, but at the same time, raises many ethical challenges. Within the field of health AI ethics, the solutions to the questions posed by ethical issues such as informed consent, bias, safety, transparency, patient privacy, and allocation are complex and difficult to navigate. The increasing amount of data, market forces, and changing landscape of health care suggest that medical students may be faced with a workplace in which understanding how to safely and effectively interact with health AIs will be essential.

Solidarity and universal preparedness for health after covid-19.

argue that our ability to control pandemics requires global action to counter inequalities from demographic, environmental, technological, and other megatrends

The European artificial intelligence strategy: implications and challenges for digital health.

In February, 2020, the European Commission published a white paper on artificial intelligence (AI) as well as an accompanying communication and report. The paper sets out policy options to facilitate a secure and trustworthy development of AI and considers health to be one of its most important areas of application. We illustrate that the European Commission's approach, as applied to medical AI, presents some challenges that can be detrimental if not addressed.

Disruptive Synergy: Melding of Human Genetics and Clinical Assisted Reproduction.

The melding of human genetics with clinical assisted reproduction, now all but self-evident, gave flight to diagnostic and therapeutic approaches previously deemed infeasible. Preimplantation genetic diagnosis, mitochondrial replacement techniques, and remedial germline editing are particularly noteworthy. Here we explore the relevant disruption brought forth by coalescence of these mutually enabling disciplines with the regulatory and legal implications thereof.

Ethical and Legal Implications of Remote Monitoring of Medical Devices.

Unlabelled: Policy Points Millions of life-sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user-downloaded smartphone applications to facilitate data relay to clinicians via manufacturer servers. Our analysis of health privacy laws indicates that most US patients may have little access to their own digital health data in the United States under the Health Insurance Portability and Accountability Act Privacy Rule, whereas the EU General Data Protection Regulation and the California Consumer Privacy Act grant greater access to device-collected data. Our normative analysis argues for consistently granting patients access to the raw data collected by their implantable devices.

Parity is Not Enough! Mental Health, Managed Care, and Medicaid.

This commentary describes limitations of mental health parity requirements in ensuring access to insurance coverage for mental health treatment and surveys regulatory options employed by states in Medicaid managed care programs as supplements to parity that can further reduce the risk of inappropriate denials of coverage.

Assisted Same-Sex Reproduction: The Promise of Haploid Stem Cells?

Same-sex couples, not unlike their heterosexual counterparts, would prefer having a genetically related child. However, assisted same-sex human reproduction has heretofore been deemed infeasible absent haploid cellular analogs of human gametes. Recent developments, however, may have overcome this limitation through the derivation of haploid embryonic stem cells (hapESCs).

Applying the proportionality principle to COVID-19 antibody testing.

As the COVID-19 pandemic continues to ravage the globe, many nations have started to relax stringent restrictions in an effort to restart the economy. While Member States of the European Union have approached reopening without the use of antibody testing for COVID-19, such testing may be central to a long-term, sustainable strategy for international travel, employment, and the allocation and monitoring of vaccines. As the use of antibody testing to dictate the enjoyment of individual freedom remains highly controversial, we describe its use in the context of three case studies (return to the workplace, travel and vaccination), applying the substantive legal balancing entailed in the proportionality principle.

Regulatory, safety, and privacy concerns of home monitoring technologies during COVID-19.

There has been increasing interest in the use of home monitoring technologies during the COVID-19 pandemic to decrease interpersonal contacts and the resultant risks of exposure for people to the coronavirus SARS-CoV-2. This Perspective explores how the accelerated development of these technologies also raises major concerns pertaining to safety and privacy. We make recommendations for needed interventions to ensure safety and review best practices and US regulatory requirements for privacy and security.

Germany's digital health reforms in the COVID-19 era: lessons and opportunities for other countries.

Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany's new (Digitale-Versorgung-Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e.