The Impact of Consumer-Monitored Health Data on Healthcare Claims
In a perfect world, health information from wearable devices would be thoughtfully received by a responsible, educated consumer and shared with healthcare providers. But the world is not perfect. Issues arising from wearable medical and health devices can have significant ramifications for healthcare liability and claims.
Data sharing and access is transforming all aspects of our lives, including how consumers tend to their health and wellbeing. Wearable medical devices, fitness trackers and a growing number of hybrid devices enable consumers to track everything from their sleep patterns, daily calories, and blood pressure, to heart rhythms and blood sugar. Consumers are increasingly empowered to make decisions about their health, often independent of a healthcare provider. An influx of apps have come to market to capitalize on the trend, allowing people to trend their health statistics, potentially "diagnose" themselves and chart their own care - including diet, medication dosages and need for emergency or other medical attention.
The companies behind these devices are often not medical providers but technology manufacturers and software companies. In 2017, the FDA saw fit to address the issue of data collected by medical devices, issuing guidance that allows a device user, upon request, to access their individual information collected by the device manufacturer. The guidance was grounded in the belief that data access would increase knowledge and promote patient engagement with healthcare providers. But it may not always work out that way. Here are some topics we are watching closely.
What is the Standard of Care?
When something goes wrong - a monitor misreads levels or a consumer misuses medication based on what their app reported, and a claim arises, who are the parties to the lawsuit? Will the medical device manufacturer, software developer and/or tech support team that provided the healthcare data be viewed as a healthcare provider? Are the users of the data considered clients, consumers, patients or some combination of the three? Should the technology support personnel fielding calls about a smart watch with an EKG feature know the signs of a cardiac abnormality? While they cannot, and should not, be expected to give medical advice, it may be reasonable to expect them to have some level of familiarity with the data provided by the product. This impacts the device maker's obligations and the standard of care by which they would be measured.
Who's assessing the data?
What happens when a weight loss app is misused by a teenager suffering from anorexia, with fatal results? Or a consumer skips a medical appointment after their phone app mistakenly assures them that their blood pressure is in check? As health information becomes commercialized and 'consumerized,' there will be a gap in education and responsible use practices. How will that gap be filled? Liability may turn on labeling and warnings. With increasingly complex devices and data, and people's health at stake, is a label or generic warning enough to guard against misuse of the information being provided?
Is the data secure?
As digital health explodes, so does the amount and nature of information stored and transmitted across devices and applications. This data could be compromised in a breach, hack or ransomware attack. Those who store the information must be prepared to protect it. With the wealth of data created, there is also the potential that those amassing data will seek to use it for economic gain. Can information be thoroughly scrubbed of personal identifiers to be sold for research or other purposes? Does such secondary use infringe on individual privacy rights?
Will complacency heighten the risk?
Despite warning labels, patients and consumers may rely solely on information they receive from wearable devices and phone apps. They may be lulled into a false sense of security and ignore clinical signs or symptoms or be left dangerously vulnerable if an application malfunctions or shuts down. What happens then, and who is responsible?
The global wearable medical devices market is slated to reach $10 billion by 2023, up from $2.7 billion in 2014. As it booms, many of the questions posed here will be answered. Case law will develop. New insurance and risk management solutions will come to market to address these emerging and multifaceted exposures. As always, Beazley will be at the forefront in helping to keep our insureds abreast and ahead of these risks. Watch this space.
About the author:
Keri Marmorek manages complex claims for Beazley’s global healthcare team. She works closely with hospital, miscellaneous medical, regulatory and international healthcare policy holders defending against third party liability claims and regulatory matters. Prior to joining Beazley in 2010, she was a practicing attorney at a New York law firm specializing in healthcare and professional liability defense.