Harvard Law Conference Surveys Troubles With Health Care

Posted on March 30, 2016 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.

It is salubrious to stretch oneself and regularly attend a conference in a related field. At the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, one can bask in the wisdom of experts who are truly interdisciplinary (as opposed to people like me, who is simply undisciplined). Their Tenth Anniversary Conference drew about 120 participants. The many topics–which included effects of the Supreme Court rulings on the Affordable Care Act and other cases, reasons that accountable care and other efforts haven’t lowered costs, stresses on the pharmaceutical industry, and directions in FDA regulation–contained several insights for health IT professionals.

From my perspective, the center of the conference was the panel titled “Health Innovation Policy and Regulating Novel Technology.” A better title might have been “How to Make Pharma Profitable Again,” because most of the panelists specialized in pharmaceuticals or patents. They spun out long answers to questions about how well patents can protect innovation (recognizing a controversy); the good, the bad, and the ugly of pricing; and how to streamline clinical trials, possibly adding risk. Their pulses really rose when they were asked a question about off-label drug use. But they touched on health IT and suggested many observations that could apply to it as well.

It is well known that drug development and regulatory approval take years–perhaps up to 20 years–and that high-tech companies developing fitness devices or software apps have a radically different product cycle. As one panelist pointed out, it would kill innovation to require renewed regulatory approval for each software upgrade. He suggested that the FDA define different tiers of changes, and that minor ones with little risk of disrupting care be allowed automatically.

I look even farther. It is well known also that disruptive inventions displace established technologies. Just as people with mobile devices get along without desktop computers and even TV sets, medicines have displaced many surgical procedures. Now the medicines themselves (particularly, controversial mental health medicines) can sometimes be replaced by interactive apps and online services. Although rigorous testing is still lacking for most of these alternatives, the biggest barrier to their adoption is lack of reimbursement in our antiquated health payment system.

Instead of trying to individually fix each distortion in payment, value-based care is the reformer’s solution to the field’s inefficient use of treatment options. Value-based care requires more accurate information on quality and effectiveness, as I recently pointed out. And this in turn may lead to the more flexible regulations suggested by the panelist, with a risk that is either unchanged or raised by an amount we can tolerate.

Comparisons between information and other medical materials can be revealing. For instance, as the public found out in the Henrietta Lacks controversy, biospecimens are treated as freely tradable information (so long as the specimen is de-identified) with no patient consent required. It’s assumed that we should treat de-identified patient information the same way, but in fact there’s a crucial difference. No one would expect the average patient to share and copy his own biospecimens, but doing so with information is trivially easy. Therefore, patients should have more of a say about how their information is used, even if biospecimens are owned by the clinician.

Some other insights I picked up from this conference were:

  • Regulations and policies by payers drive research more than we usually think. Companies definitely respond to what payers are interested in, not just to the needs of the patients. One panelist pointed out that the launch of Medicare Part D, covering drugs for the first time, led to big new investments in pharma.

  • Hotels and other service-oriented industries can provide a positive experience efficiently because they tightly control the activities of all the people they employ. Accountable Care Organizations, in contrast, contain loose affiliations and do not force their staff to coordinate care (even though that was the ideal behind their formation), and therefore cannot control costs.

  • Patents, which the pharma companies consider so important to their business model, are not normally available to diagnostic tests. (The attempt by Myriad Genetics to patent the BRACA1 gene in order to maintain a monopoly over testing proves this point: the Supreme Court overturned the patent.) However, as tests get more complex, the FDA has started regulating them. This has the side effect of boosting the value of tests that receive approval, an advantage over competitors.

Thanks to Petrie-Flom for generously letting the public in on events with such heft. Perhaps IT can make its way deeper into next year’s conference.