Reconceptualizing Consent for Direct-to-Consumer Health Services

Abstract

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy--but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach? This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing. DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that "includes" reports that meet FDA qualifications, despite disclaimers of intent to "provide medical advice." The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller. This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics

“…50 There is debate about what law and rules govern the advertising and contracting process, that is, the informed consent. 51 In seeking the customer's business, the company must clearly and accurately describe the services offered; misrepresentation or fraud may be actionable under state law or ground investigation and penalty by the Federal Trade Comission (FTC). 52 The FDA may impose labeling and consent requirements.…”

The Critical Role of Medical Institutions in Expanding Access to Investigational Interventions

“…Yet, at other times, minor physiological risks are unacceptable to a patient due to other quality‐of‐life considerations. But the clinical risk‐benefit analysis is tailored to the individual . In research, the underlying premise of equipoise generally compels us to render this balance differently: benefits may not redound to any individual patient, and we must weigh risks we expect research participants to accept at the cohort level.…”

Should Clinicians Leave “Expanded” Carrier Screening Decisions to Patients?

“…9 Expanded carrier screening products test all patients for the same carrier conditions-whatever their reported family history, race, or ethnicity-and are generally exempted from US Food and Drug Administration approval due to the perceived low risk of any one piece of information being a false positive. 10 Currently, 15% of obstetricians report offering expanded carrier screening to all of their patients and 52% of obstetricians report ordering expanded carrier screening upon patient request. 11,12 Proponents of expanded carrier screening argue that testing everyone for everything can identify more couples at risk of having an affected fetus in an increasingly diverse country and that the use of expanded carrier screening does not rely on patients having accurate knowledge of their ancestry or family history.…”