Nothing symbolizes this revolution more than Apple’s healthcare-oriented iWatch, expected in early 2015. Increasingly, ordinary people can utilize devices, apps, medical tests, and data analysis to take charge of their health in a proactive way. Perhaps the most powerful emerging tool is consumer genomics—the still-nascent field of decoding people’s genetic data to help them (and their doctors) make decisions about everything from diet to medical treatment.
Until recently, the limited data most of us had was not much more than blood pressure readings and a weight check from our annual physical, or an occasional temperature reading during flu season. And we frequently—sometimes with relief—forgot what we learned. Now that digital and wireless technologies put day-to-day measurement, data, and judgment into their hands, individuals have more information and more responsibility. How many steps did you take today? Calories did you consume? Hours did you sleep? Heartbeats did you have?
Whether that trend will lead to radically empowered consumers or to hopelessly confused patients depends very much on whom you ask. Experts are splitting into two camps: those who believe people should have unfettered access to more data, and others who contend people are not equipped to deal with all this information without expert guidance.
“It is just morally wrong to deny anybody access to data on themselves, whether it is their medical record or molecular data generated on them,” says Eric Schadt, director of a genomics institute at the Icahn School of Medicine at Mount Sinai in New York. “If genetic data is generated on me, I should not only own those data, but I should have the right to choose who I want to share those data with.”
The anti-empowerment naysayers tend to be cautious regulators and traditionalists. Last year, the U.S. Food and Drug Administration ordered consumer genetics pioneer 23andMe to stop giving health-related data even to paying customers, because its service had not been reviewed and approved by the agency.
One key virtue of the new world of self-measurement, says Mount Sinai’s Schadt, is that it frees us from limiting past conceptions of “health” that were themselves crudely constructed from population averages. He says devices that continually measure heart rate, blood pressure, blood oxygen levels—and track that data over long periods of time—“can help establish reliable baselines for your own personal health, where deviations … may be far more predictive of health-related issues than the population-based guidelines.” Schadt compares it to watching the indicators on the dashboard of your car, which can alert you well before a breakdown. Such monitoring, he says, “is not just about avoiding catastrophe. It is about maintaining a more optimal [health] state that can enhance your performance physically and mentally.”
Having access to more data can enable consumers to assemble a more accurate picture of their own health—one that may help explain what’s going on when they’re sick. Sometimes the self-diagnosis has outperformed doctors. Kim Goodsell, a 56-year-old California woman, was diagnosed with two rare diseases. Though doctors insisted these were separate conditions, she refused to accept the astronomical odds of having two unrelated, very rare diseases. Though she’s no medical expert, Goodsell spent years combing through genetic research and eventually found a single mutation linked to both rare diseases. Testing confirmed she had what was indeed a single, previously unknown disease. Since then, Goodsell has come up with a dietary program that helps mitigate her symptoms.
Slowly, the biomedical community and regulatory agencies are recognizing that consumers will demand access to this kind of data. “People want the information and there’s no reason they’re not entitled to it,” says William Hoffman, who chronicles the rise of consumer genomics in his recent book, The Biologist’s Imagination. Indeed, just this year, then-HHS secretary Kathleen Sebelius ruled that patients should have direct access to lab test results, which had formerly been accessible only to physicians. “Information like lab results,” she said at the time, “can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans.”
Concerns and Consequences
But the FDA and others worry about how consumers will respond to health data, particularly when it comes to complex genetic information like that provided by 23andMe. Extensive studies, however, have shown that consumers tend to receive this kind of information calmly, even in potentially high-stress situations like learning they have a genetic risk for an untreatable disease such as Alzheimer’s. Mount Sinai’s Schadt notes that people can make bad decisions based on any kind of data—financial, political, and so on—but that in most situations we accept that risk because we presume that people do better with more information. If regulators continue to drag their feet, service providers may just move to countries with less stringent guidelines and offer the information online.
That doesn’t mean regulation has no role. As author Hoffman points out, “The FDA does have the responsibility to insist that what companies say about personal health information based on genetic data is accurate and can be verified.” That’s why many companies offering consumer-oriented tests or devices require that a physician order them and be responsible for presenting the results. Regulatory agencies want a doctor or genetic counselor to be an intermediary. But an increasing challenge is that many medical professionals are themselves not equipped to explain results—particularly from genetic tests. Several studies have found that only a small fraction of physicians feel confident they know when to order a genetic test or can understand the results.
No matter how much health data individuals may be able to handle, it’s unclear whether we can trust business to handle it. This is an area where regulators may still need to protect us. Big companies are routinely failing to protect consumer financial data, especially credit card information. Can we trust them when it comes to our (far more personal) health data? Already, marketing firms are selling data linking consumers to health conditions or diseases, often based on information people entered in surveys or online forms. While U.S. law protects medical data shared between a clinician and a patient, fitness information in an app, for instance, is at present legal fair game for marketers. So we will need to protect our health information both from criminal theft and unscrupulous mishandling.
Despite these challenges, consumers want to measure and monitor just about anything. More than 20 percent of consumers are already using some sort of self-monitoring technology, according to a study from Accenture. The big future business opportunity may be in helping consumers store and interpret what they gather from devices, sensors, and tests. We could certainly use tools that pull disparate data together and assemble it into a big picture.
Like so many other tech-infused realms, healthcare is heading toward a flattened world of consumer empowerment. “This extreme paternalism that permeates much of medicine must be changed,” says Schadt. The most likely result of the explosion in consumer technology will be a healthier society.
This article appears in the 2014 Year-End Edition of Techonomy Magazine.