Category Archives: Health Care

New Washington Law Has Broad Implications For Protecting Consumer Health Data

by Nancy Libin, Adam H. Greene, Rebecca L. Williams, David L. Rice, Michael T. Borgia, John D. Seiver, and Kate Berry

Photos of the authors

Top row from left to rugh: Nancy Libin, Adam H. Greene, Rebecca L. Williams, and David L. Rice.
Bottom row from left to right: Michael T. Borgia, John D. Seiver, and Kate Berry. (Photos courtesy of Davis Wright Tremaine LLP)

Landmark ‘My Health My Data’ Act Reaches Beyond Washington and Into the Courts With a Private Right of Action

On April 27, 2023, Washington Governor Jay Inslee signed into law the My Health My Data Act (the “Act”), which will regulate the collection, use, and disclosure of “consumer health data” (“Consumer Health Data” or “CHD”). The Act is intended to provide stronger privacy and security protections for health-related information not protected under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), but a significant gap remains. In spite of its title and purported focus on the health information of Washington residents, a careful reading of the Act shows that it will have a much broader reach – both geographically and substantively. Most provisions of the Act come into effect on March 31, 2024, with small businesses required to comply by June 30, 2024. Some sections (e.g., Section 10 prohibition against “geofencing”) do not provide effective dates. It is unclear whether those sections become effective on July 22, 2023, which would be 90 days after the end of the legislative session, as provided under Washington law, or whether failure to include an effective date for all sections of the Act was an oversight.

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FTC Continues Enforcement Focus on the Use and Disclosure of Health Information for Advertising

by Kirk J. Nahra, Ali A. Jessani, Arianna Evers, and Samuel Kane

Author photographs

From left to right: Kirk J. Nahra, Ali A. Jessani, Arianna Evers, and Samuel Kane. (Photos courtesy of Wilmer Cutler Pickering Hale & Dorr LLP.)

On Thursday, March 2, the FTC announced an enforcement action against BetterHelp, Inc., an online mental health counseling service, relating to claims that the company’s collection and use of consumer health data were unfair and deceptive acts and practices under Section 5 of the FTC Act. As part of the settlement, BetterHelp will be required to pay $7.8 million, which the FTC will use to provide partial refunds for consumers who enrolled in and paid for BetterHelp services between August 2017 and December 2020. The BetterHelp enforcement decision comes just over a month after the FTC reached a historic settlement order with another company in the healthcare space, GoodRx, for similar alleged violations.

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SCOTUS Overrules Roe v. Wade – Part IV: The Impact of Dobbs on Data Privacy – FTC v. Kochava

by Shoba Pillay, Madeleine V. Findley, Ann M. O’Leary, Anne Cortina Perry, Dawn L. Smalls, Alison Stein, and Philip B. Sailer

The Federal Trade Commission (FTC) recently filed a complaint against a data broker alleging that the collection and sale of precise location data significantly harms consumers, especially if the data contains information regarding travel to and from specific sensitive locations, such as reproductive healthcare clinics. The outcome of the case could have a substantial impact on the FTC’s authority to enforce consumer protection laws and will likely inform how companies handle consumer data to which they have access. The FTC’s complaint follows guidance the Biden administration issued to federal agencies, including the FTC, to take actions to protect consumers’ privacy in connection with reproductive healthcare services  after the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (“Dobbs”)[1]. The outcome of the case could have a substantial impact on the sale and collection of consumer location data and the FTC’s authority to enforce consumer privacy protections.

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Neither Carrots nor Sticks: DOJ’s Unfulfilled Commitment to Corporate Health Care Compliance

by Jacob T. Elberg

In October, Deputy Attorney General (“DAG”) Lisa Monaco assured an audience of white collar defense counsel,“[C]ompanies serve their shareholders when they proactively put in place compliance functions and spend resources anticipating problems. They do so both by avoiding regulatory actions in the first place and receiving credit from the government. Conversely, [the Department of Justice] will ensure the absence of such programs inevitably proves a costly omission for companies who end up the focus of department investigations.”[1]

This aspect of DAG Monaco’s speech drew little attention, as the Department of Justice (“DOJ”) has for decades sought to encourage four compliant behaviors in corporate actors: maintenance of an effective compliance program before the onset of government scrutiny (pre-existing compliance program), post-enforcement adoption of an effective compliance program, cooperation with a government investigation, and self-disclosure of misconduct. While DOJ’s public statements reflect a claimed commitment to all four, analysis of DOJ policy and resolved cases makes clear that as DOJ has increasingly prioritized and incentivized the latter three behaviors, the first—an effective pre-existing compliance program, the only one aimed towards stopping fraud before it occurs—has been cast aside in one of DOJ’s highest-profile enforcement areas: health care fraud.

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The Biden White House Ramps up Antitrust Enforcement and Reform

by Ann O’Leary, Tom Perrelli, Katie Johnson, Sarah Norman, Phil Sailer, Laurel Raymond

I. Introduction

On July 9, 2021, President Biden signed Executive Order 14036, “Promoting Competition in the American Economy”[1] (the “EO”). The sweeping competition EO, coupled with six competition bills[2] advanced by a bipartisan vote of the House Judiciary Committee in June, signals a sustained focus on competition policy from both the White House and Congress, and that focus is set to only intensify over the next year in the lead up to the midterms. Continue reading →

The House Oversight Committee Investigative Agenda for the Next Two Years Highlights Likely Private Sector Targets for Congressional Investigations

by Robert Kelner, Brian Smith, Angelle Baugh, Brendan Parets, Perrin Cooke, Bill Sokolove, and Darcy Slayton

On May 21, the House Committee on Oversight and Reform’s “Oversight Plan” was published, after being submitted for publication by Committee Chairwoman Carolyn Maloney (D-NY) over a month ago. The Oversight Plan outlines the “topics designated for investigation, evaluation, and review” by the Committee over the next two years. The Oversight Plan provides a very useful roadmap of the Committee’s investigative priorities and should be seen as a fair warning to the industries and companies identified in the plan.

The Committee’s Oversight Plan is required by the House Rules. Under House Rule X, Clause 2, each standing committee of the House is required to submit an oversight plan to the Oversight Committee. The Oversight Committee then reviews the plans and reports to the full House on each committee’s plan and the Oversight Committee’s recommendations for coordinating oversight activities. The 2021 Oversight Plan included the Oversight Committee’s compilation that, along with its own plan, included the oversight plans of all other House committees. The nearly 300-page compilation generally indicated an interest in oversight of the coronavirus crisis, health care, economic prosperity and infrastructure investments, and climate change and the environment.

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Health Care Fraud Means Never Having to Say You’re Sorry

by Jacob T. Elberg

The Securities and Exchange Commission’s use of “neither admit nor deny” settlements[1] continues to garner significant attention a decade after Judge Rakoff took aim at the policy. Most recently, authors on this blog used data from the Securities Enforcement Empirical Database (SEED) to examine the prevalence of “neither admit nor deny” settlements, as well as admissions of guilt, concluding that the SEC has, “albeit slowly, shifted away from the more aggressive prosecutorial stance instituted under Chair [Mary Jo] White” – a more aggressive stance taken in the wake of criticism from Judge Rakoff,[2] Senator Elizabeth Warren,[3] and countless commentators and scholars.

Strangely, while the SEC’s use of “neither admit nor deny” settlements continues to be the focus of criticism suggesting it is too lenient, there has been no similar criticism of the Department of Justice’s use of the False Claims Act, which plays a parallel role in health care enforcement to that of the SEC’s enforcement of the securities laws. Continue reading →

Life Sciences Companies Face Heightened Insider Trading Risks and Scrutiny

by Anne E. Railton and Courtney D. Orazio

Insider trading has long been a key enforcement priority for the U.S. Securities and Exchange Commission (SEC) and the U.S. Department of Justice (DOJ).  The COVID-19 pandemic has caused market volatility not seen in decades, creating heightened concerns about insider trading that have only sharpened this focus.  Life sciences companies—including biotechnology, pharmaceutical, medical device, and healthcare product and services businesses—are likely to be particular subjects of scrutiny.  Already frequent targets of SEC and DOJ focus even before the pandemic, many life sciences companies on the frontlines of fighting COVID-19 have been privy to a regular stream of material COVID-related, market-moving information.  The ongoing opportunities for breakthroughs in responding to the pandemic create opportunities for lucrative trading, too—and regulators and prosecutors have taken notice.  Life sciences companies, along with their executives and directors, have already—and will continue to—face scrutiny arising out of event-driven trading issues relating to COVID-19 diagnostics, treatments, and vaccines. 

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Document Retention in EU Competition Cases

by Alejandro Guerrero and David Wood

On 25 March 2021, the Court of Justice of the EU (“CJEU”) confirmed the fines imposed in Europe on a number of pharmaceutical companies, including Xellia and Alpharma, for entering into anticompetitive ‘pay for delay’ settlement agreements. 

One of the grounds of appeal rejected by the CJEU concerned the impact of the lengthy administrative procedure on Xellia’s and Alpharma’s rights of defence.  The CJEU found that Xellia and Alpharma had not proven that the Commission’s investigatory steps had taken so long as to impact their rights of defence.  In particular, Xellia and Alpharma could not blame the Commission for their own failure to preserve documents that could have assisted their defence. Continue reading →

U.S., EU, U.K., and Other Antitrust Enforcers Enter Collaboration on Antitrust Analysis of Pharma Deals

By D. Jarret Arp, Arthur J. Burke, Ronan P. Harty, Howard Shelanski, and Jesse Solomon

On March 16, 2021, a coalition of international and U.S. antitrust authorities announced their formation of a joint working group to reevaluate their approach to reviewing mergers in the pharmaceutical industry (which today relies largely on an indication-by-indication review of the competitive overlaps between the merging parties).  The issues the working group plans to address are broad and cover theories of harm, analytical methodologies, and remedies.  The formation of this group highlights that pharmaceutical deals will remain a key priority for antitrust agencies—and indicates the potential emergence of more aggressive enforcement that has implications for deal timing, the scope of agency engagement, and increased multilateral collaboration among reviewing agencies.

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