Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from (1) establishment of a healthcare relationship, (2) state licensure laws, and (3) reimbursement. We analyze these areas because of the legal ambiguities or inconsistencies they raise depending on the state, which seem to be hampering telehealth growth without necessarily improving quality of care. We propose several solutions for a more unified approach to telehealth regulation that incorporate core bioethics principles of doctor-patient relationship, competence, patient autonomy, as well as population-wide questions of resource allocation and access. Lawmakers should clarify that healthcare relationships may be established outside of in-person meetings, align licensure laws via an interstate compact or federal preemption, and expand Centers for Medicare and Medicaid plans to reimburse telehealth delivery in the home.

The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.

Discovery of strongly-lensed gravitational wave (GW) sources will unveil binary compact objects at higher redshifts and lower intrinsic luminosities than is possible without lensing. Such systems will yield unprecedented constraints on the mass distribution in galaxy clusters, measurements of the polarization of GWs, tests of General Relativity, and constraints on the Hubble parameter. Excited by these prospects, and intrigued by the presence of so-called “heavy black holes” in the early detections by LIGO-Virgo, we commenced a search for strongly-lensed GWs and possible electromagnetic counterparts in the latter stages of the second LIGO observing run (O2). Here, we summarise our calculation of the detection rate of strongly-lensed GWs, describe our review of BBH detections from O1, outline our observing strategy in O2, summarize our follow-up observations of GW170814, and discuss the future prospects of detection.

Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of “over-compliance,” and makes recommendations for reform.

This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority—especially under the Commerce Clause—to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could be an effective and legally viable tool for the protection of public health.