Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Clash of Titans? A Brewing Dispute between Telehealth Giants

By Vrushab Gowda

Competition between rival telehealth providers spilled into open conflict last month, as incumbent Teladoc Health, Inc. (Teladoc) filed a patent infringement suit against relative upstart American Well Corporation (Amwell).

This development marks a significant escalation in what has been a lengthy arms race between the two publicly traded entities. Both having witnessed skyrocketing sales in recent months, aided by a shift to virtual care and a host of regulatory flexibilities, although neither has turned a profit to date.

Read More

Miami Downtown, FL, USA - MAY 31, 2020: Woman leading a group of demonstrators on road protesting for human rights and against racism.

Understanding the Role of Race in Health: Conclusions from the Symposium

By Craig Konnoth

In my introductory post to this symposium, I suggested that medicine and health tapped into a discourse of power that had the power to either harm or help. Medicine can trigger benefits in the law — what I call “medical civil rights,” where advocates rely on medicine’s language to trigger both formal legal rights and public advantage. At the same time, I acknowledged that black, indigenous, and people of color (BIPOC), are often left behind.

In a midpoint reflection, I theorized the problem through the lens of a double bind. On one hand, medicine erases the needs of BIPOC and the harms they experience — the health harms experienced by frontline medical workers, or caused by school and residential segregation — so that they cannot access medical civil rights. On the other hand, BIPOC are rendered hypervisible in contexts where medicine continues to oppress. They are used in clinical trials and tarred with xenophobia and narratives of genetic difference. What should be done?

Several authors offer solutions. I separate them into three categories: (1) community reform, (2) social and legal reform, and (3) medical reform. Of course, all of these solutions are interrelated. Legal and policy change drives medicine; medical research drives law, society, and policy — and both are driven through community activism and consciousness.

Read More

A calculator, a stethoscope, and a stack of money rest on a table.

Telemedicine is No Cure for Fraud and Abuse

By Vrushab Gowda

The exponential growth of telehealth in recent years has revolutionized the delivery, access, and cost of care. Unfortunately, it is not immune to the fraud and abuse that divert nearly $70 billion from the health care system annually.

A rise in suspect practices has been accompanied by a concomitant escalation of Department of Justice (DOJ) enforcement, sending a clear signal to would-be fraudulent actors.

The ongoing Operation Rubber Stamp is one such enforcement thrust. A joint initiative of the of the Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS), it targeted an extensive network of telemedicine fraud totaling over $4.5 billion in false claims and yielding thirty guilty pleas to date.

Read More

computer and stethoscope

Is Real-World Health Algorithm Review Worth the Hassle?

By Jenna Becker

The U.S. Food and Drug Administration (FDA) should not delay their plans to regulate clinical algorithms, despite challenges associated with reviewing the real-world performance of these products. 

The FDA Software Pre-Certification (Pre-Cert) Pilot Program was designed to provide “streamlined and efficient” regulatory oversight of Software as a Medical Device (SaMD) — software products that are regulable by the FDA as a medical device. The Pre-Cert program, in its pilot phase, is intended to inform the development of a future SaMD regulatory model.

Last month, the FDA released an update on Pre-Cert, highlighting lessons learned from pilot testing and next steps for developing the program. One key lesson learned was the difficulty in identifying and obtaining the real-world performance data needed to analyze the clinical effectiveness of SaMDs in practice. Although this challenge will be difficult to overcome in the near future, the FDA’s plans to regulate should not be slowed by insufficient postmarket data.

Read More

an ambulance parked at the entrance of an emergency department

The Double Bind of Medicine for Racial Minorities

By Craig Konnoth

Medicine often falls short of helping black, indigenous, and people of color (BIPOC). While many individuals successfully invoke medical framing to offer some assistance to address the serious burdens they face — as I explain in a recent article — such efforts have fallen short in the context of racial justice. BIPOC are either subject to hypervisibility — where their medical trait is made a defining characteristic of their existence — or medical erasure, where their medical needs are left unaddressed and ignored.

Read More

Empty hospital bed.

Addressing Health Inequities in End-of-Life Care in the Era of COVID-19

By Megan J. Shen

Inequities in end-of-life care have been exacerbated by the COVID-19 pandemic, but have yet to receive the same level of attention as some other health disparities brought to the fore recently.

Quality end-of-life care is focused on reducing human suffering and aiding patients in receiving support during the dying process.

Traditionally, poor quality end-of-life care involves the overtreatment of patients, as in the case of continuing to treat incurable cancer aggressively. However, COVID-19 has introduced new challenges in achieving quality care at the end of life. Specifically, it is now more challenging to reduce human suffering at the end of life because of limitations in providing access to two critical resources: (1) medical care that can relieve physical suffering in the dying process and (2) support, such as loved ones, as well as needed psychological, spiritual, and physical support to cope with the existential threat of dying. COVID-19 has made access to both of these a greater challenge for underrepresented minorities.

Read More

computer and stethoscope

How Telehealth Could Improve — or Worsen — Racial Disparities

By Craig Konnoth, JD, M.Phil., Wendy Netter Epstein, JD, and Max Helveston, JD

Despite upping the stakes of America’s partisan divide, the pandemic has prompted bipartisan support for at least one cause — the rapid rollout of telehealth, which allows people to see their doctors by videoconference or telephone.

In last week’s executive order, the Trump Administration reaffirmed its commitment to the use of telehealth. While telehealth may be, in many ways, a panacea for access to healthcare, particularly in COVID times, we should be concerned that patients of color may be left behind.

Read More

Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Regulation of Access to Clinical Data in Chile’s New Constitution

By Gabriela Y. Novoa and Alexis M. Kalergis

As Chileans prepare to vote on whether or not to create a new Constitution, an issue worth considering relative to this reform concerns access to clinical data.

The Political Constitution of the Republic of Chile dates back to 1980, and, in the past decades, has undergone several amendments, including key reforms in August 1989, August 2005, and August 2019. As part of this last modification, it was agreed to organize a plebiscite to democratically decide whether or not to elaborate an entirely new constitutional text. If the alternative of generating a new constitution is adopted, it will consist of a constitution written from square one, rather than a modification to the existing text.

As part of the public discussion relative to the potential approval of the need for a new constitution, an open debate has taken place about which issues should or should not be incorporated into this new text.

Among several important themes, the need to regulate the access to clinical data of patients, also called “interoperability,” arises as a major one. Such an issue is linked to the rights to life, to health and privacy protection, individual honor and personal data and property, which are currently established as constitutional guarantees by Article 19 of the current Constitution. Further, the legal framework dealing with this issue is currently mainly found in Law No. 20,584, which regulates the Rights and Duties of individuals in connection with actions associated to their health care, and in Law No. 19,628 (on the protection of the privacy of individuals).

Read More

Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

A New Step for the FDA in Regulating Digital Health Products

By Vrushab Gowda

On September 22, the U.S. Food and Drug Administration (FDA) announced the establishment of a new initiative to regulate digital health products – the Digital Health Center of Excellence (DHCoE).

In some ways, the announcement does not come as a surprise; FDA Commissioner Stephen Hahn’s predecessor, Scott Gottlieb, outlined the DHCoE in a press release two years ago. What does remain to be seen is whether DHCoE represents a true paradigm shift in FDA’s approach to regulating digital health products.

According to Hahn, the DHCoE aims to (1) build partnerships, (2) share knowledge across FDA and with stakeholders, and (3) innovate regulatory approaches. It will be led by the current Director of CDRH’s Division of Digital Health, Bakul Patel.

Read More

Close-up Of Doctor's Hand Measuring Blood Pressure Of Male Patient.

Understanding the Role of Race in Health: A New Digital Symposium

By Craig Konnoth

In the 1980s, a vanguard of critical race theorists debated their contemporaries as to whether law could or should play a role in achieving equity — in particular, racial equity. Scholars such as Kimberlé Crenshaw and Patricia Williams argued that while legal discourse historically had been used to oppress Black, Indigenous, and people of color (BIPOC), history had shown that in the law also lay the seeds of empowerment. Conceptualizing BIPOC as persons endowed with legal rights, and as a community subject to heightened legal solicitude because of the historical injustices they have faced, has helped undergird their selfhood, dignity, identity and activism. Law could thus be a discourse of despair — but also one of hope.

Whether or not the years have proved those claims correct as to the law, today, a similar debate unfolds in the context of race, medicine, and health care. Today, medicine and the health care system embody discourses of power that rival the law. Will these discourses inevitably serve to oppress BIPOC — and if not, how can we harness their power to achieve justice? Those are the questions that this symposium seeks to answer.

Read More