People use health-related items more frequently, many of which cross regulatory lines they are unaware of and never see. There is a distinction between diagnostic items that are subject to FDA regulation and more broadly applicable wellness products. The use of general wellness products by patients and doctors must be taken into account in the future of diagnostic excellence, and rules must be revised appropriately. A growing number of direct-to-consumer products are made with the intention of assisting people in evaluating their health. For instance, the smartphone app Hyfe tracks users' coughing habits and provides data on their overall respiratory health. Users of Google's dermatological app can snap pictures of their skin lesions to aid in the detection of possibly cancerous growths. An Apple Watch's electrocardiogram (ECG) feature allows users to identify atrial fibrillation. While most users might treat all three gadgets equally, only the Apple Watch's ECG app has been subject to any FDA regulatory assessment. Besides examining the challenges, the line poses for regulation, physician use and interpretation, consumer understanding, privacy, and reimbursement. This Viewpoint describes the issues raised by products that blur the line between medical devices and low-risk general wellness products.
The way the FDA now regulates a product depends on how it works. What is the product's intended usage, and how much risk does it present to the user? Devices, as defined by the FDA as products "designed for use in the diagnosis of disease or other conditions, or in the cure, prevention, mitigation or treatment of disease," are distinguished using this strategy. By contrast, the FDA defines low-risk general wellness products as products that-
(1) are to be used by people for only general wellness
(2) present highly lower risk to users/people safety
The FDA won't regulate general wellness items if they just advocate for a healthy lifestyle or help lower the risk of specific chronic diseases based on established therapies, even though some of these products may be considered "devices" by some people.
The distinction between these two product categories is not often obvious, especially to consumers—take, for instance, the difference between the dermatological app from Google and the ECG app from Apple. They are unlikely to comprehend whether these products have undergone any safety and efficacy reviews. Confusion is increased by the fact that, despite apparent differences in their regulatory categories, both the Google and Apple apps appear to be focused on diagnosis. This worry is made worse by retail product marketing that emphasizes how these things improve general health. Consumers' access to information about specific products, including product marketing, is restricted by the law. The regulatory status of general wellness products may provide their manufacturers more freedom to make unsubstantiated health claims than is the case with device manufacturers. Patients may have a harder time suing if they utilize the results of general wellness products to guide their medical decisions because they do not claim to diagnose or treat a disease or condition. Similar to the situation involving OTC drugs, the FDA may demand comprehension tests. Yet, doing so would necessitate FDA regulation of the product as a device. The Federal Trade Commission (FTC) has the jurisdiction to regulate advertisements to ensure that they are not unfair, false, or misleading, even if the FDA does not have the authority to oversee more general retail technology. Although capacity concerns would prohibit it, one potential answer is for the FTC to concentrate its enforcement efforts on specific product categories (such as general wellness items). In addition to legal enforcement, there may be occasions to convene medical professionals, patients, and carers to properly establish expectations for how outcomes from general wellness products should be used.
Doctors can be certain that a controlled technology is secure and efficient when they receive results from it. Nevertheless, what should doctors do if a patient appears with knowledge obtained from general wellness products? How familiar with the underlying technology that generates the data must clinicians be? What if, as Hyfe does with coughing, the findings only track a possible symptom of numerous diseases or ailments but the app offers no explanation of what the observed data mean? Physicians may spend time without being paid to try to comprehend how each general wellbeing product shows facts and figuring out how sensitive and specific those data are. Doctors must also decide whether and how much to rely on information produced by tools like Google's dermatological app. They could make erroneous diagnoses if they accept the material at face value and do not request confirmation or follow-up testing. This worry is made more pressing by the fact that general wellness products differ significantly in their specificity and sensitivity from FDA-regulated tests, and doctors often don't have the time or resources to "dig under the hood" of these items. On the other hand, patients could be dissatisfied if the information they provide to their doctor is disregarded or if they are required to pay for additional tests they believe are unnecessary. In the context of direct-to-consumer genetic testing, related problems have emerged. It would be helpful to provide doctors further instructions on how to handle these data, such as telling them to interpret the information as suggestive rather than conclusive, similar to how they would handle family history or symptom reporting. Clearer practice guidelines, which courts frequently employ to establish the standard of care for malpractice, may be helpful in this situation.
The product line for devices vs. general wellbeing has important privacy consequences. The Health Insurance Portability and Accountability Act of 1996 (HIPAA), the most well-known federal privacy legislation, only applies to specific types of information gathered or sent by "covered entities," such as doctors' offices, hospitals, and their business partners. Several retail technologies, like those used in general wellness items, are not covered by it. Customers might not recognize how utilizing a retail product vs a prescribed device differs in terms of privacy concerns. Congress might raise the level of privacy protection for these items to that of HIPAA, but it has generally shown little interest in privacy reform. Furthermore, it is unclear whether the law properly shields patient information from improper or harmful uses, even when HIPAA's privacy provisions are in effect. The realities of reimbursement must be used to dampen the enthusiasm some inventions inspire. Insurance may pay for specific diagnostic gadgets, but general wellness products' value propositions are less guaranteed, and insurance coverage is thus less certain. Retail general wellness items might not benefit all patients equally, even if they can enhance patient outcomes. This could be because certain patients find the products too expensive to use, or because specific patient groups are underrepresented in the data sets. Those with modest incomes might not be able to afford the products or the supporting equipment needed to use the product, especially as diagnostics move to smartphones and tablets (eg, a smartphone needed to run an app). Updating public insurance reimbursement models to cover gadgets differently, including the cost of apps that can run on smartphones, is one potential solution to solve this issue partially.
The proliferation of these gadgets makes it crucial to think ahead about future legal and medical remedies. While there is no ideal remedy, hazards can be reduced. A comprehensive strategy will be needed to address the issues with at-home diagnostic products, one that involves working with the FDA, FTC, and other federal agencies to create new laws and procedures and possibly conduct more studies on emerging technologies and the dangers they pose. In order to create best practices and standards as well as educational campaigns, it will also be necessary to bring together patients, physicians, device makers, technology companies, nonprofit organizations, academics, and government officials. Solutions must also take into account prospective regulatory alterations, but any changes must significantly improve upon the FDA's current risk-based approach. FDA regulations already put devices into multiple regulatory routes based on the risk level, including for the riskiest devices "risk from false positive or false negative outcomes for diagnostics. The FDA's position is likely to be that low-risk general wellness items, including devices, do not make claims related to any diseases or conditions; as a result, this level of risk is taken into account when determining the device's classification. Yet when businesses blur the line between wellness items and diagnostic devices, it can be challenging to determine what counts as a diagnostic for regulatory purposes and what doesn't. Any regulatory changes must also take into account how compliance costs may affect innovation in the industry.