telehealth

The FTC has made news recently with its recent enforcement activity regarding companies’ alleged disclosures of consumer health data, as detailed in our recent post FTC to Advertisers: We’re tracking Your Use of Health information, and as evidenced by the FTC’s tentative agenda for its next open meeting later this month on potential rulemaking regarding amending the Health Data Breach Notification Rule (a point which is curious given its prior policy statement already attempting to expand its scope, which we discussed here).

Aside from regulators, however, Plaintiffs’ lawyers also are paying attention to the FTC’s activity of law, and, on a parallel track, has initiated a wave of consumer class actions regarding the use of tracking pixels and consumers’ “health information” have followed. We anticipate this wave will only increase in response to Washington’s My Health, My Data Act once in effect.

Continue Reading The FTC is Not the Only One Tracking Your Use of Health Information

On April 27, 2023, Washington Governor Jay Inslee signed into law the My Health My Data Act (MHMD). The law has an effective date of July 23, 2023, but the deadline to comply with most of its requirements is March 31, 2024.*  While the 2023 state legislative season may see the addition of four comprehensive privacy laws (Iowa, Indiana, Montana, and Tennessee), My Health My Data (HB 1155) could have the most far-reaching impact on businesses. 

Although limited to “consumer health data,” MHMD’s actual scope is much broader than many might anticipate based on the title of the law. It imposes stringent notice, consent, and HIPAA-style authorizations to the collection, sharing, and sale of “consumer health data,” a term that captures a potentially vast array of data. MHMD also creates a private right of action, allowing consumers to bring claims under Washington’s Consumer Protection Act, in addition to authorizing enforcement by the state attorney general.

MHMD also fits a broader trend toward intense scrutiny of health information practices under state privacy laws, through FTC enforcement actions, and in private class actions.

This post takes a look at some of the key requirements and open questions under MHMD, and offers a few tips to help stay ahead of increasingly strict health privacy regulations.

Continue Reading My Health My Data: Washington’s Health Data Privacy Revolution

For the second time in as many months, the Federal Trade Commission (FTC) last week announced a settlement alleging that a company’s use and disclosure of consumers’ health information for online advertising violated the law.  The BetterHelp settlement indicates that the FTC takes a broad view of what constitutes “health information,” but it raises questions about how the FTC will apply its reinterpretation of the Health Breach Notification Rule under its September 2021 policy statement.

Overview of the FTC’s Broad View of “Health Information”

BetterHelp is an online counseling service that has registered more than 2 million users since its 2013 inception.  When a consumer visits the site, the FTC alleges that she is “immediately prompted to begin” Better Help’s intake questionnaire that asks questions about the consumer’s history of therapy, current mental state, and religious beliefs among other characteristics, and then provides an email address and other information to create an account.

According to the FTC’s complaint, the company violated the FTC Act through its use of advertising pixels or web beacons and by uploading consumers’  “health information” to ad platforms for retargeting and to reach additional prospects. In the FTC’s view, the “health information” that BetterHelp disclosed not only included information about consumers’ past use or current enrollment in the company’s services but also their interest in obtaining therapy. This information was sufficient to “reveal” that consumers were “seeking mental health treatment.”

Continue Reading FTC to Advertisers: We’re Tracking Your Use of Health Information

A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention.  As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased almost 30% since the pandemic began, according to CNBC.  And there is a wide variety of options to choose from,

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a universe unto itself, overseen by the FDA pursuant to the Prescription Drug Marketing Act. As prescription drug companies have increased their direct-to-consumer outreach through social media, native advertising, and health information platforms, questions have arisen as to the role that the NAD might play in regulating these advertisements.  For those who are unfamiliar, the NAD is the National Advertising Division of the Better Business Bureau.  It is an industry self-regulatory body that is charged with hearing and rendering decisions in advertising disputes, typically among competitors.  It is commonly used amongst advertisers of consumer-directed products and services.  It is not commonly used amongst prescription drug advertisers and, until recently, many likely assumed that NAD did not have jurisdiction to hear prescription drug advertising challenges.

A relatively recent NAD decision makes clear that that body believes that it has jurisdiction over prescription product advertising, however. Late last year, the NAD evaluated advertising by Synergy Pharmaceuticals for its Trulance product, which is prescribed for chronic idiopathic constipation.  Allergan, maker of a competing product, challenged the advertising on the basis that it included false implied superiority claims, expressly false superiority claims, and undisclosed native advertising in the form of a waiting room pamphlet that allegedly was positioned as independent and impartial patient education material. 
Continue Reading Think Your Prescription Drug Advertising is Beyond NAD’s Purview? NAD Disagrees.

The FTC announced late last week that it resolved its case against the final defendant, Avrom Lasarow, in the “Melanoma Detective” app matters.  The FTC alleged that claims that the apps could detect and diagnose melanoma in its early stages were not supported by competent and reliable scientific evidence.  As we discussed here, the

The Federal Trade Commission announced this week that it has reached settlements with two marketers for “deceptively claiming their mobile apps could detect melanoma, even in its early stages.” MelApp and Mole Detective claim to have the ability to accurately screen for a mole’s analyzed melanoma risk despite the absence of clinical testing. The FTC

The annual International Consumer Electronics Show (CES), held each year in early January, is a showcase for the latest gadgetry trends.  The recently-concluded CES 2015 featured innovation in a variety of forms, not the least of which are products with a health-related focus.  From the FitBit to track steps to the Quitbit to track progress in quitting smoking, the number of products recording consumer behavior continues to proliferate.

Techies and ordinary consumers aren’t the only ones interested in all things electronic, however.  Numerous government agencies have jurisdiction over these products depending on their functionality, including the Federal Trade Commission (FTC), the Food and Drug Administration (FDA), and the Federal Communications Commission (FCC).  A few products featured at this year’s CES demonstrate this intra-agency overlap.

For example, the “Breathometer Breeze Breathalyzer” features the following claims:  it can detect blood alcohol levels with the same degree of accuracy as policy breathalyzers, tell consumers when their blood alcohol content will be 0.0, and has a “home safe” function that allows consumers to call a car service or friend to help them get home safely. The product purportedly is a Class I medical device that can connect to smartphone apps via Bluetooth.

Continue Reading From FitBit to Quitbit: The Role of Federal Agencies and Consumer Electronics