Direct-to-consumer digital health
Authors: Adam B Cohen, Simon C Mathews, E Ray Dorsey, David W Bates, Kyan Safavi
Journal: The Lancet Digital Health (2020)

Unlike many other medical products and services, digital health technologies are often sold directly to, and used by, individual patient consumers. These technological offerings can address unmet health-care needs by circumventing traditional intermediaries, such as payers (eg, insurance companies and governments), clinicians, employers, and the pharmaceutical industry, and provide patients with direct access to health-related data and services. Like other industries that empower consumers with easily accessible information and services, direct-to-consumer digital health might similarly transform health care. Fitness trackers, sleep monitors, and wearables that detect arrhythmias are the current leading technologies. Direct-to-consumer health care already represents a US$700 billion industry and includes over-the-counter drugs, care management in retail clinics, hearing aids, glasses, contact lenses, and nutraceuticals. The direct-to-consumer approach attracts companies because this part of health care offers a large customer base and few regulatory barriers to entry. Given these benefits, it should be no surprise that digital health companies are entering the direct-to-consumer domain. Using the Rock Health Digital Database,1Rock HealthDigital health funding database.https://rockhealth.com/data/funding-raw-data/Date accessed: August 28, 2018Google Scholar which profiles digital health companies based in the USA that received more than $2 million in publicly disclosed funding from 2011 to 2019, we found that 252 (21%) of 1214 digital health companies pursued a direct-to-consumer strategy. This cohort of 252 digital health companies represented 36% of the 702 companies offering technologies directly related to patients. Direct-to-consumer, digital health companies disclosed the receival of $7·3 billion in funding during this period. For reference, 450 (37%) of the 1214 digital health companies focused on patient care without a direct-to-consumer approach, and received $13·5 billion of funding, and 512 (42%) of the 1214 companies did not focus directly on patient care (eg, some companies focused on billing) and received $12·2 billion of funding. Direct-to-consumer digital health is a growing industry that can address unmet patient needs by directly engaging patients. The direct-to-consumer approach might be particularly helpful for those without consistent access to care because of financial, social, cultural, or geographical barriers. For example, web-based applications for the screening of participants at clinical high-risk for psychosis have shown success in the provision of readily accessible services in a manner perhaps as effective as traditional screening methods in the clinic.2Uhlhaas P Torous J Digital tools for youth mental health.NPJ Digit Med. 2019; 2: 104Crossref PubMed Scopus (14) Google Scholar, 3McDonald M Christoforidou E Van Rijsbergen N et al.Using online screening in the general population to detect participants at clinical high-risk for psychosis.Schizophr Bull. 2019; 45: 600-609Crossref PubMed Scopus (39) Google Scholar Other example technologies that directly engage patients include activity trackers that aim to prevent cardiovascular disease, watches to detect atrial fibrillation, and telemedicine services to replace visits to emergency departments. Although the attractiveness of these products to consumers is clear, direct-to-consumer products bypass the typical filters and safeguards of health-care systems. The risk is that low value, or even harmful, products will inundate the commercial health-care market. There are cautionary instances of high-profile direct-to-consumer companies, such as uBiome and Theranos, that have suspended operations after quality and ethical concerns over their products surfaced.4Dockser Marcus A The ethics of experimenting on yourself.https://www.wsj.com/articles/the-ethics-of-experimenting-on-yourself-1414170041Date: Oct 24, 2014Date accessed: February 2, 2020Google Scholar, 5Ioannidis JP Stealth research: is biomedical innovation happening outside the peer-reviewed literature?.JAMA. 2015; 313: 663-664Crossref PubMed Scopus (47) Google Scholar Even companies with good intentions are challenged to balance the rapid and iterative nature of technological development with the deliberative and cautious nature of medicine. As the direct-to-consumer, digital health industry grows, these risks must be carefully assessed by regulators, clinicians, and researchers to maximise benefit and minimise risks to the public. The US Food and Drug Administration (FDA) is seeking to effectively regulate the quality and safety of digital health while not impeding the rapid, iterative innovation characteristic of the industry. The current Precertification (Pre-Cert) Pilot Program in digital health provides preapproval of software medical devices made by companies that the US FDA has identified as meeting the standards of excellence in quality and safety.6US Food and Drug AdministrationPrecertification (Pre-cert) Pilot Program: milestones and next steps.https://www.fda.gov/medical-devices/digital-health-software-precertification-pre-cert-program/precertification-pre-cert-pilot-program-milestones-and-next-stepsDate: July, 2019Date accessed: February 2, 2020Google Scholar Although this approach is novel and could be effective for a subset of products, the programme will not suffice for the continuous deluge of direct-to-consumer technologies, which are targeting increasingly complex clinical indications, inundating the market. Direct-to-consumer products that make explicit claims about wellness and lifestyle but imply health benefits for serious medical conditions are particularly concerning. These products easily bypass the current regulatory radar. For example, a fitness product might imply health benefits for patients with cardiovascular disease despite never being tested in these patients. Individuals with advanced heart failure might use the product unaware of the potential harm. President Theodore Roosevelt signed a US law in 1906 that mandated standards for food labelling. This law was the first of its kind in the USA and ultimately led to the creation of the US FDA. The US FDA is now “responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled”7US Food and Drug AdministrationGuidance for industry: food labeling guide.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-labeling-guideDate: September, 1994Date accessed: February 2, 2020Google Scholar and, since the 1970s, has established comprehensive, nationwide requirements for food labelling. The US FDA is familiar with establishing requirements for industry that provide consumers with specific information to better understand products. These facts about nutrition are ubiquitous on food product labels and provide consumers with interpretable data on key consumer health questions, thereby empowering consumers to make informed choices. Although imperfect and evolving, food labelling represents a scalable solution for the constant entry of new food and nutritional products into the market. Digital health products would benefit from a similar model.8Mathews SC McShea MJ Hanley CL Ravitz A Labrique AB Cohen AB Digital health: a path to validation.NPJ Digit Med. 2019; 2: 38Crossref PubMed Scopus (153) Google Scholar A label, either virtual or physically affixed to the product, detailing digital health facts would help to guide consumers (and clinicians) with succinct, understandable information that addresses questions in key domains, many of which have been previously outlined.8Mathews SC McShea MJ Hanley CL Ravitz A Labrique AB Cohen AB Digital health: a path to validation.NPJ Digit Med. 2019; 2: 38Crossref PubMed Scopus (153) Google Scholar What does this product measure? How accurate is this measurement? What will the product do for me (or my patient)? Was the product tested in people like me (or my patient)? Have there been adverse events caused by the product? Is my data safe and where will my data go? By ensuring companies explicitly state the product's purpose and limitations, the US FDA will help to differentiate high quality products from low quality products in a scalable manner among the immense number of direct-to-consumer digital health products. Just as nutrition labelling led to a healthy food revolution in the USA, a label of digital health facts could drive consumer demand towards products that are able to support explicit health claims and motivate companies to compete on quality and value. Clinicians also have a crucial role in helping patients to navigate their health. However, direct-to-consumer products inherently bypass clinicians, prompting concerns from professional medical societies that represent clinicians. Professional societies have complained about teeth alignment kits, home genetic tests, hearing aids, heart rhythm monitors, neurostimulation devices, and novel mental health tools.9Wexler A Joffe S 5 ways to address the challenges of direct-to-consumer health products.https://www.statnews.com/2019/04/02/address-challenges-direct-to-consumer-health-products/Date: April 2, 2019Date accessed: December 23, 2019Google Scholar The ability of the clinician to have a valuable role in guiding the patient is hampered by the continuous and rapid entry of direct-to-consumer digital health products into the market, the pace of which outstrips that of traditional medical drugs and devices. Furthermore, the absence of a common language to describe the facts about digital health leaves consumers and their clinicians confused. Patients arrive at clinics with product-derived data and request interpretation of such data. Patients also request recommendations on whether to purchase digital health products. Alongside patients, clinicians have an important role in the identification, guidance, and development of direct-to-consumer digital health products and frameworks. Existing frameworks have suggested that developers should pay more attention to user-focused design, privacy, and problems users care about, like help during emergencies.10Torous J Nicholas J Larsen ME Firth J Christensen H Clinical review of user engagement with mental health smartphone apps: evidence, theory and improvements.Evid Based Ment Health. 2018; 21: 116-119Crossref PubMed Scopus (300) Google Scholar Professional societies, as a complement to regulatory bodies, could play a crucial role in educating clinicians on digital health, as is already done with traditional medical products. The efforts of the Society of Behavioral Medicine and the American Psychiatric Association exemplify this approach. In addition to being stewards of safe health care, professional societies should identify specific areas of unmet need under the current health-care system, such as the monitoring of precursors of disease in large populations. Such professional medical societies can also work with emerging organisations focused on digital health that are developing standards for digital health and advocating for evidence-based digital health products and services. Examples of these organisations focused on digital health include the Digital Medicine Society, Digital Therapeutics Alliance, HealthXL, and NODE.Health. The research community has a fundamental role in supporting regulators and clinicians by providing rigorous evaluations of the validity and efficacy of digital health products. The paucity of published, high quality clinical data is perhaps the biggest contributor to the potential risk related to digital health companies. Even well funded, established companies have marketed products supported by no or few peer-reviewed research studies.11Safavi K Mathews SC Bates DW Dorsey ER Cohen AB Top-funded digital health companies and their impact on high-burden, high-cost conditions.Health Aff (Millwood). 2019; 38: 115-123Crossref PubMed Scopus (40) Google Scholar These studies have generally contained low level evidence of validity and efficacy, with respect to the hierarchy of evidence, and primarily included healthy volunteers, rather than individuals with high-burden diseases.11Safavi K Mathews SC Bates DW Dorsey ER Cohen AB Top-funded digital health companies and their impact on high-burden, high-cost conditions.Health Aff (Millwood). 2019; 38: 115-123Crossref PubMed Scopus (40) Google Scholar Researchers can produce data that regulators can directly bring to consumers via labels of digital health facts, published studies, reports, and digital health data commons. Organisations that fund grants, such as the Patient-Centered Outcomes Research Institute, could greatly facilitate impact-focused activity in digital health by issuing funding calls to action. As evidence accumulates, data should be synthesised by professional medical societies to enable clinicians to better understand the data and communicate these data to their patients. As the industry of direct-to-consumer digital health moves from vague purpose and indistinct clinical metrics toward specific intent with clear clinical metrics, we expect this industry to become increasingly impactful. We also expect this trend to produce technologies validated in specific populations. In this context, regulators would approve products supported by studies that show that these products improve outcomes, costs, or access for specific patients with specific diseases. As the capabilities of technology advance, the need for more robust validation and development of digital health infrastructure, guidance, and regulation continues to grow.8Mathews SC McShea MJ Hanley CL Ravitz A Labrique AB Cohen AB Digital health: a path to validation.NPJ Digit Med. 2019; 2: 38Crossref PubMed Scopus (153) Google Scholar DWB consults for EarlySense, receives cash compensation from the Center for Digital Innovation (Negev), receives equity from Valera Health, CLEW Medical, and MDClone, and will be receiving research funding from IBM Watson Health. ERD is a member of the medical advisory board of, and owns stock options in, Grand Rounds, consults for MC10, and has research grants related to telehealth from AbbVie, Burroughs Wellcome Fund, Greater Rochester Health Foundation, the National Institutes of Health, the Patient-Centered Outcomes Research Institute, and the Safra Foundation. KS receives equity in Position Health. ABC consults for Pear Therapeutics and Thirty Madison, and has stock options in Thirty Madison. SCM declares no competing interests. The authors declare no competing, non-financial interests. ABC and KS conceived the main concepts of this Comment and acquired data from the Rock Health Digital Database, interpreted these data, and analysed these data. ABC, KS, SCM, DWB, and ERD interpreted these data, and wrote and edited the manuscript.