Regulating Mobile Mental Health Apps

Mobile medical apps (MMAs) are a fast‐growing category of software typically installed on personal smartphones and wearable devices. A subset of MMAs are aimed at helping consumers identify mental states and/or mental illnesses. Although this is a fledgling domain, there are already enough extant mental health MMAs both to suggest a typology and to detail some of the regulatory issues they pose. As to the former, the current generation of apps includes those that facilitate self‐assessment or self‐help, connect patients with online support groups, connect patients with therapists, or predict mental health issues. Regulatory concerns with these apps include their quality, safety, and data protection. Unfortunately, the regulatory frameworks that apply have failed to provide coherent risk‐assessment models. As a result, prudent providers will need to progress with caution when it comes to recommending apps to patients or relying on app‐generated data to guide treatment

UNDER-REGULATED HEALTH CARE PHENOMENA IN A FLAT WORLD: MEDICAL TOURISM AND OUTSOURCING

This Article examines two intersecting phenomena: medical tourism and the outsourcing of health care goods and services. "Medical Tourism" (Part I) involves the resident of one state or country physically experiencing health care in another place. "Out- sourcing" (Part II) involves care that appears domestic but has been disaggregated to allow some components to be performed non-do- mestically. Frequently the patient (or in the case of final benefi- ciaries of a clinical trial, a domestic user of a subsequently approved drug) does not know that care has been outsourced. These two phenomena currently operate outside, and may be disruptive of, contemporary Western health care regulation. While health care, particularly in the U.S., is our most highly regulated industry, medical tourism and outsourcing appear to operate outside our traditional regulatory matrix. Having examined the ex- tent to which this is an accurate intuition, this Article questions (in Part III) the extent to which we do or will enjoy increased trading of health services and addresses some of the issues that must be considered in approaching any regulatory questions posed by medi- cal tourism and outsourcing

Regulatory Disruption and Arbitrage in Health-Care Data Protection

This article explains how the structure of U.S. health-care data protection(specifically its sectoral and downstream properties) has led to a chronically uneven policy environment for different types of health-care data. It examines claims for health-care data protection exceptionalism and competing demands such as data liquidity. In conclusion, the article takes the position that health­ care-data exceptionalism remains a valid imperative and that even current concerns about data liquidity can be accommodated in an exceptional protective model. However, re-calibrating our protection of health-care data residing outside of the traditional health-care domain is challenging, currently evenpolitically impossible

COVID-19 and healthcare lessons already learned

COVID-19 has exposed deep-rooted flaws in our health system regarding healthcare financing and delivery. This essay uses COVID-19 as a frame to reflect on the growth in our uninsured population, the flaws inherent in healthcare federalism, how “Trumpcare” has made things worse, the magnified importance of Medicaid, and the problems inherent in relying primarily on private actors

Will the Internet of Things Transform Healthcare?

Emerging technologies like health apps on mobile computing platforms and wearable devices are believed to have the potential to improve individual and population health. Increasingly, however, attention should extend to a far larger cohort of connected devices known as the Internet of Things (IoT), an environment in which devices communicate with each other, health apps, and wearables. The resulting Internet of Health Things promises to do things conventional health providers either cannot do or do them faster and cheaper. First, services are always on, providing twenty-four/seven monitoring of the patient or pre-patient. Second, the multiple sensors contained in smartphones or second-generation wearables like the Apple Watch are professional grade. Third, our smartphones and wearables are highly context aware, with knowledge of place, environmental factors, and, increasingly, other people and things around us. Fourth, they are smart and capable of learning, often leveraging sophisticated, cloud-based analytics. However, the Internet of Health Things (IoHT) is, at least in comparison to conventional health care, unregulated or, at best, underregulated. This Article identifies and analyzes three areas of concern: (1) effectiveness and quality, (2) data protection (including pre-patient expectations), and (3) device safety and quality. The Article concludes by examining ways in which the IoHT can improve both traditional healthcare and create new, disruptive approaches to technologically mediated care