Apple watch and fit bit.

Beyond HIPAA: A Proposed Self-Policing Framework for Digital Health Products

By Vrushab Gowda

As digital health products proliferate, app developers, hardware manufacturers, and other entities that fall outside Health Insurance Portability and Accountability Act (HIPAA) regulation are collecting vast amounts of biometric information. This burgeoning market has spurred patient privacy and data stewardship concerns.

To this end, two policy nonprofits – the Center for Democracy and Technology (CDT) and the eHealth Initiative (eHI) – earlier this month jointly published a document detailing self-regulatory guidelines for industry. The following piece traces the development of the “Proposed Consumer Privacy Framework for Health Data,” provides an overview of its provisions, and offers critical analysis.

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AI concept art.

A Closer Look at FDA’s Newly Released AI/ML Action Plan

By Vrushab Gowda

The U.S. Food and Drug Administration (FDA or “the Agency”) recently issued its long awaited AI/ML (Artificial Intelligence/Machine Learning) Action Plan.

Announced amid the closing days of Stephen Hahn’s term as Commissioner, it takes steps toward establishing a dedicated regulatory strategy for AI products intended as software as a medical device (SaMD), versus those embedded within physical hardware. The FDA has already approved a number of such products for clinical use; however, AI algorithms’ self-learning capabilities expose the limitations of traditional regulatory pathways.

The Action Plan further outlines the first major objectives of the Digital Health Center of Excellence (DHCoE), which was established to much fanfare but whose early moves have remained somewhat unclear. This document presents a policy roadmap for its years ahead.

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Code on computer.

How to Secure Our Digital Health Infrastructure Against Cyber Attacks

By Vrushab Gowda

Our health information infrastructure is highly susceptible to cyber attacks. At the time of writing, the Department of Health and Human Services (HHS) is actively investigating over 700 major breaches over the past 24 months alone.

It is incumbent upon our institutions to proactively guard against these threats, with our federal government leading the charge.

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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.

HHS Recognizes Key Role of Telehealth in Amended PREP Act Declaration

By Vrushab Gowda

On December 3rd, the Department of Health and Human Services (HHS) extended its provisions to cover telehealth services in amending its Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID–19.

This represents the first time HHS has covered telehealth services under the authority of the PREP Act. Telehealth providers are now permitted to deliver a range of COVID-related care across the country, including states in which they do not hold professional licenses. The Declaration, moreover, offers them expansive liability protection, effectively immunizing them against a host of claims in connection to their administration of designated countermeasures.

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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.

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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.

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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.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

The Promise and Pitfalls of Trump’s “Most Favored Nation” Approach to Drug Pricing

By Vrushab Gowda

On September 13th, President Trump issued an executive order aimed at addressing ballooning pharmaceutical expenditures.

The order seeks to apply a “most favored nation” scheme to prescription drug payments made through Medicare Parts B and D, which are currently on track to exceed $130 billion. Although ambitious in scope, the order’s ultimate impact remains to be seen.

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Person typing on computer.

Telehealth Policy Brought to the Fore in the COVID-19 Pandemic

By Vrushab Gowda

The COVID-19 pandemic has highlighted the value of telehealth as both a tool of necessity (e.g., minimizing infection risk, conserving thinly stretched healthcare resources, reducing cost) as well as of innovation.

Telehealth services have surged in recent months; in April alone, they constituted over 40 percent of primary care visits nationwide and over 73 percent of those in Boston. “Increasing Access to Care: Telehealth during COVID-19,” a recent publication in the Journal of Law and the Biosciences, dissects the issues that have accompanied the growth of telehealth and identifies further areas of potential reform.

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