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If Employers Can’t Improve Individuals’ Health, How Can Accountable Care Organizations?

Posted on June 11, 2015 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

There seems to be a healthy competition among companies to pump up their staff’s participation in “wellness” programs. One recent poll of employers found that 60% offer incentives of some type for healthy behavior. But beyond anecdotal evidence, rigorous studies are casting doubt on the effectiveness of wellness programs. And that makes me wonder: will doctors face the same problems while trying to bend the health cost curve?

Talk to employers, and most will gush with enthusiasm over their wellness programs, which are spreading far and wide in the U.S. But at last week’s Health Privacy Summit, law professor Lindsay Wiley reviewed the literature and found a very different picture. A clinical study of a weight loss program found that the average weight loss it produced was…one pound. Other studies found that if people lost weight or stopped tobacco use to earn financial incentives, they “bounced back” and regained the weight or resumed smoking. Often, weight gains were more than what had been lost.

We should acknowledge that wellness programs take many forms, some showing more promise than others. General initiatives to put healthier food in cafeterias and vending machines seem benign. Incentives for employees to join a gym and get regular medical check-ups also seem successful in meeting those goals. But what health reformers really hope for–whether in the workplace or through clinical efforts such as Accountable Care Organizations–is thorough-going behavior change. Long-term lifestyle practices that reduce the incidence of diabetes, heart failure, etc. are what both employers and insurers seek in order to reduce the costs of health care plans. And that’s just where the wellness programs haven’t demonstrated results.

The panel in which Wiley participated also covered other weaknesses of fitness programs. Some 18% tie incentives to the output of fitness devices or other biomarkers, and nearly 50% intend to move in that direction in the future. But many consumer devices are inaccurate. Furthermore, many are easy to deceive by employees determined to game the system. There are even videos online that tell people how to manipulate results.

Concerns over privacy and discrimination run through these systems. Any device given by an employer to an employee–a Fitbit just as much as a laptop–remains the property of the employer, and so does the data on that device. Do we want employers to have unrestricted access to everything a device says about us? Walls keeping personal data in fitness programs away from human resource departments are insubstantial and easy to penetrate.

It’s disappointing that we lack firm evidence that wellness programs can lead to life-enhancing behavioral changes. But the lessons we learned from employees also have upsetting implications for the rest of the health care system. The whole premise of risk sharing (such as in ACOs) is that clinicians can persuade their patients to reject a lifetime of unhealthy eating, smoking, and sedentary habits. What if they can’t? Are clinicians being set up to fail? Bob Kocher suggested as much in a panel at the recent Health Datapalooza, when he pointed out that many patients have serious and multiple chronic conditions that are hard to turn around.

Some ACOs are demonstrating cost savings through low-hanging fruit, such as calling up patients to remind them to come to appointments or take their medications. These can make a big difference, but after we’ve exhausted the benefits of these simple interventions, how can we move to the next level of changing lifestyles?

I do have hope for lifestyle change. It will involve a lot more than crude incentives. It will require a clinician or other professional to form a trust relationship with a patient. It will require a lot of education. And technology can probably help. If integrated into a clear, individualized plan that the patient buys into, communications technologies and sensors can help patients stick to their commitments.

Health is also a community effort–a key point lost in the rush to wellness programs. Setting up such programs implies that each person is responsible for his or her own health. It moves the blame from social trends in food, transportation, air quality, etc. to individuals.

The workplace is where we spend an increasing number of our waking hours, so it makes sense to put the workplace in the spotlight of health care efforts. But we must let wellness programs whitewash employers’ responsibility for increasing stress, providing ergonomically destructive environments, or disrupting employees’ sleep. A recent Dilbert cartoon is relevant here. Let’s each take responsibility–as employers, as clinicians, as public health officials, and as individuals–for the things over which we have control.

Annual Evaluation of Health IT: Are We Stuck in a Holding Pattern? (Part 3 of 3)

Posted on April 15, 2015 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The previous installments of this article covered major regulatory initiatives and standards projects. Some of the same questions have a direct impact on technological advances.

Medical Devices: Always With You, But Neither Here Nor There

One ad I saw compares a fitness device to a friend whispering in your ear wherever you go. Leaving aside control freak issues, what could be better for a modern patient with a condition that responds to behavior change than a personal device? Through such devices, we can implement a 24/7 cycle of medical care. We can also save enormous sums of money by treating the patient in his natural environment instead of a hospital or rehab facility.

The rapid spread of health devices was a foregone conclusion even before Apple thrust it into the mainstream with HealthKit. Last month’s launch of ResearchKit suggests that Apple will do the same for the big data revolution in health care championed by the Personal Genome Project, 23andMe (now back in the business after being reined in by the FDA), PatientsLikeMe, and other pioneer organizations. Apple Watch, an indulgence expected to grab the hearts of the affluent, might pull off the paradigm shift in how we interact digitally that Google Glass aimed at.

For these devices to make the leap from digital pets to real medical intervention, including a strengthening of the bond between clinicians and patients, they must satisfy stringent requirements for safety and accuracy. Current FDA regulations distinguish (in very rough terms–I am not a lawyer) between devices that make diagnoses or recommend treatments and other devices that merely measure vital signs or deliver reminders. If you make a diagnosis or recommend a treatment, you need to undergo a complex and expensive evaluation. People can also submit problems they find about your device to FDA’s medical device database.

Safety, accuracy, and transparency are goals well worth pursuing. The problem is not the cost of certification techniques, but the vast gulf between the development model assumed by certification and the one followed by modern developers of both software and hardware.

Development methods nowadays are agile. Developers incrementally release versions of software or hardware and upgrade them every few months. But certification processes require retesting every time the smallest change is made. And that’s reasonble because any tweak (even a configuration change out in the field) can cause a working device to fail. Such certifications work well for embedded systems in airplanes and nuclear facilities, and even critical medical devices that may live in patients’ bodies for decades. But they slow innovation to a crawl and raise prices precipitously.

Oddly enough, the tension between agile development and certification affects medical devices and electronic health records (EHRs) equally, and EHRs are equally prone to errors or misleading interfaces. Yet medical devices are regulated while EHRs are not. This contradiction must be resolved–but perhaps not by dropping the anvil of safety certification on all software used in medicine. The FDA can search for a more supple regulatory process that blesses certain classes of hardware and software while allowing for variation within them, backed up by guidelines for robust development and testing.

The FDA understands that it’s in an untenable situation but doesn’t know what to do. They have shaved off certain devices and marked them for lower levels of scrutiny, such as devices that transfer or display data collected elsewhere. The FDA has also led a muddled discussion over a national “test bed” for medical devices. More regulatory clarity in the area of both devices and EHRs, along with a push by regulators and users for better development practices, could help the field take off and realize the promise of personal devices.

Conclusion

I’m excited about the possibilities of health IT, but concerned that the current environment is insufficiently friendly for its deployment. On top of all the other factors I’ve cited that hold back the field, consider the urgent shortage of health IT staff. Providers and development firms have been bidding up salaries to steal each other’s employees, and attempts to increase the pool have shown disappointing results.

What I hear is that IT experts would love to get into health care, knowing that it can help the public immensely as well as pay off financially. But they have balked at the technical and working conditions in the field: hide-bound institutions, 50-year-old standards and tools, and of course the weight of standards and regulations to study.

How many of these topics will be covered at HIMSS? FHIR will be widely considered, I know, and the buzz over Meaningful Use is always strong. The question what will prod change in the system. Ultimately, it may come from a combination of consumer demand and regulatory pressure. Progress for the sake of progress has not been a prominent trait of health IT.