Defeating Death (And Taxes)

“It is one of the most powerful tools our species has created. It helps doctors fight disease. It can predict global weather patterns. It improves education for children everywhere. And now, we unleash it…on your taxes.”

Super Bowl 2017 was an absolute cracker. My passport is not American and my accent is not Bostonian, but somewhere amidst the drama and the crowd and the cheesy nachos, I was drawn in and hooked. I roared and gasped and choked on cheap beer all the way to that nail-biting finish. Go Pats.

But, as it was my very first Super Bowl, I was told to keep an eye on the ads. Sure enough, they were hilarious, inspiring, maddening and perplexing by turn. One of them, however, hit me harder than Keanu Neal.

This ad, from H&R Block, announced that they will be using IBM’s Watson to deliver their services. Watson is, perhaps, the most impressive artificial intelligence that our species has yet produced. H&R Block is a consumer tax services provider.

Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from pharmacist-industry relationships, to returns from six-month market exclusivity extensions, to financial conflicts of interest among patient advocacy organizations. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ. 2017;356:i6770.
  2. Califf RM. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. JAMA. 2017 Jan 20. [Epub ahead of print]
  3. Hakim A, Ross JS. High Prices for Drugs With Generic Alternatives: The Curious Case of Duexis. JAMA Intern Med. 2017 Jan 23. [Epub ahead of print]
  4. Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff (Millwood). 2017 Jan 18. [Epub ahead of print]
  5. Kesselheim AS, Treasure CL, Joffe S. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 2017;14(1):e1002190.
  6. Rose SL, Highland J, Karafa MT, Joffe S. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest. JAMA Intern Med. 2017 Jan 17. [Epub ahead of print]
  7. Saavedra K, O’Connor B, Fugh-Berman A. Pharmacist-industry relationships. Int J Pharm Pract. 2017 Jan 18. [Epub ahead of print]

A New Day For Oversight Of Human Subjects Research

This new post by Holly F. Lynch appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

On January 19, 2017—President Obama’s last day in office—the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.” This rule change had been a long time coming, with an Advance Notice of Proposed Rule Making (ANPRM) published in July 2011 and a Notice of Proposed Rule Making (NPRM) published in September 2015. The seriousness of its impact on the research community, patients, and the public is evidenced by the more than 3,300 public comments submitted during the rulemaking process. So what changed?

First, it is important to understand where things stood. The Common Rule was initially adopted in 1991, with each relevant agency codifying the same set of regulations (the Department of Health and Human Service’s codification is found at 45 C.F.R. Part 46). The primary functions of the Common Rule are to require that research with human subjects be approved by an Institutional Review Board (IRB) and that subjects provide informed consent to research participation, with some important exceptions on each front. (FDA has similar, but not identical requirements, for clinical investigations, which are now likely to be harmonized with the new Common Rule.) […]

Continue reading here.

Housing Equity Week in Review

This week was all about fair housing. Particularly, the Affirmatively Further Fair Housing rule and recent attempts to dismantle it. Here’s the round-up for last week, January 29 – February 5, 2017:

We’ve talked a little about fair housing before. In case you missed it, we interviewed Christopher Bonastia about his book, “Knocking at the Door” back in November.

Did we miss any big housing, law and equity stories this week? Let us know!

Looking Forward: The Next Generation of Biosimilars

Looking Forward: The Next Generation of Bio
similars

February 7, 2017 12:00 PM

Description

Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product, like a generic drug.

This panel of experts will discuss the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics include how the next generation of biosimilars can improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.

Panelists

This event is free and open to the public. Lunch will be provided.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Tort Law: Public and Private

By Alex Stein

Readers interested in medical malpractice might be interested in seeing—and commenting on—my new article, The Domain of Torts, forthcoming in 117 Colum. L. Rev. (2017).

This Article advances a novel positive theory of the law of torts that grows out of a careful and extensive reading of the case law. The Article’s core insight is that the benefit from the harm-causing activity determines the form and substance of tort liability. This finding is both surprising and innovative, since tort scholars universally believe that the operation of the doctrines that determine individuals’ liability for accidents—negligence, causation, and damage—is driven by harms, not benefits. The key role of benefits in the operation of our tort system has eluded the searching eye of scholars, even though it is fully consistent with the case law.

Specifically, this Article shows that our tort system operates in two parallel modes—private and public—rather than just one, as conventional accounts erroneously suggest. Furthermore, the system’s mode of operation and the rules allocating liability for accidental harm are dictated by the type of the benefit sought by the alleged tortfeasor. If the benefit sought by the tortfeasor is purely private, she will be held liable for the harm resulting from her actions whenever she exposes her victim to a nonreciprocal risk. The tort system never allows actors to inflict harm on others when the benefit they seek to derive from their activity is purely private, no matter how significant that private benefit is relative to the victim’s harm. The system consequently does not hesitate to discourage the production of private benefits even when they are economically more valuable than the victim’s safety. That is, in cases of private benefit, tort law excludes cost-benefit analysis in favor of the reciprocity and equality principles. When the benefit that accompanies the harm-causing activity is public, by contrast, tort law adopts a strictly utilitarian approach and focuses exclusively on minimizing the cost of accidents and the cost of avoiding accidents as a total sum. Liability in such cases is imposed based on the famous Learned Hand formula (and similar formulations). Accordingly, if the benefit from the harm-causing activity is greater than the expected harm and precautions are too costly, no liability will be imposed. The consequent reduction in the victim’s protection is counterweighted by society’s need not to chill the production of public benefits that the victim enjoys on equal terms with all other members of her community. Continue reading

Chimeras with benefits? Transplants from bioengineered human/pig donors

By Brad Segal

In January of this year, Cell published a study modestly titled, Interspecies Chimerism with Mammalian Pluripotent Stem Cells. It reports success bioengineering a mostly-pig partly-human embryo. One day before, Nature published a report that scientists had grown (for lack of a better word) a functioning genetically-mouse pancreas within the body of a genetically-modified rat. The latest study raises the likelihood that before long, it will also be scientifically possible to grow human organs within bioengineered pigs.

The implications for transplantation are tremendous. But hold the applause for now. Imagine a chimera with a brain made up of human neurons which expressed human genes. Would organ procurement without consent be okay? That troubling possibility raises  questions about whether manufacturing chimeras with human-like properties for organs is even appropriate in the first place. Here’s what University of Montreal bioethicist Vardit Ravitsky told the Washington Post:

“I think the point of these papers is sort of a proof of principle, showing that what researchers intend to achieve with human-non-human chimeras might be possible … The more you can show that it stands to produce something that will actually save lives … the more we can demonstrate that the benefit is real, tangible and probable — overall it shifts the scale of risk-benefit assessment, potentially in favor of pursuing research and away from those concerns that are more philosophical and conceptual.”

I respectfully disagree. Saving more lives, of course, is good. Basic science is also valuable – even more so if it might translate to the bedside. This line of research, though, is positioned to upend our entire system of transplantation, and so its implications go beyond organ supply. In this post I will argue that to assess this technology’s implications for organ procurement in particular, there is good reason to focus on harms, not benefits. Continue reading

‘Safe spaces’ in adverse health incident investigation and patient complaints

By John Tingle

Two new reports, one by Action against Medical Accidents,(AvMA),the charity for patient safety and justice and the other by the Patient’s Association charity, (PA), highlight once again significant  problems with NHS (National Health Service) patient safety investigative and complaints structures and procedures.

The Department of Health, (DH) in 2016 produced a consultation paper which closed on 16th December 2016 on providing a ‘safe space’ in healthcare safety investigations.

This is linked to the new NHS, Healthcare Safety Investigation Branch (HSIB),operational from April 2016, and when fully functional will  offer support and guidance to NHS organizations on investigations, and carry out certain investigations itself.Current Government policy is to consider the development of a ‘safe space’ in serious adverse health incident investigations. The Consultation paper stated:

“…many believe that the creation of a type of ‘strong wall’ around certain health service investigations, so that information given as part of an investigation would only rarely be passed on, would provide a measure of ‘psychological safety’ to those involved in investigation, allowing them to speak freely. This will enable lessons to be learned, driving improvement and ultimately saving lives.” (p.8). Continue reading

The 21st Century Cures Act: One of Many Reasons Why Today’s Executive Order Is Misguided

Today, President Trump signed an executive order (EO) whose purpose is ostensibly to reduce the regulatory burden imposed by the government on many different types of industries.  The EO envisions achieving this goal through an incredibly sophisticated strategy: “for every one new regulation issued, at least two prior regulations be identified for elimination.”  Not how burdensome any particular regulation is, or how old it is, or how broad it is – just how many regulations there are.

The next question, of course, is what the EO means by “regulation.”  It clearly includes traditional APA notice-and-comment rulemaking (the EO specifically calls out situations when an agency “publicly proposes for notice and comment” a regulation).  More generally, the EO does provide a definition: “For purposes of this order the term “regulation” or “rule” means an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

This sounds to me as if it includes guidance documents, which are used extensively by many agencies to set and implement policy. To be sure, it is not always clear what counts as a guidance document, and it is not always clear whether agencies are attempting to use guidance to circumvent the notice-and-comment rulemaking process.  But by many common definitions of guidance documents (including those put forth in executive orders by the Bush Administration, for instance), the term “regulation” as defined in this EO would seem to include guidance documents.  As with other EOs issued in the past week, this one could have benefited from more clarity, but I think the better reading of the EO is that it does cover guidance.

There are many reasons why this strategy in general is a bad one, but I’ll focus on just one: the need to develop policy as a result of particular statutes.  Take the 21st Century Cures Act.  Whatever your view of its merits, it passed with overwhelming bipartisan support in the last weeks of President Obama’s administration.  It also imposes enormous new obligations on HHS and the FDA to make all kinds of policy judgments going forward.  It rarely requires the creation of a traditional notice-and-comment rulemaking (see sections 4002 and 4003 for examples), but often speaks in terms of “establish[ing] a program” or “establish[ing] a draft framework,” much of which could be done through guidance.

Continue reading

Housing Equity Week in Review

Last week, January 23-29, 2017, saw a mix of national and local-level housing news. Here’s our round-up for the past week:

  • Surprising some on the “Warren-wing” of the Democratic Party, Elizabeth Warren came out in support of Dr. Ben Carson as the 17th Secretary of Housing and Urban Development. In the confirmation hearing, Warren asked Carson if he can promise that no taxpayer dollar will go from HUD to developments’ of Donald Trump, then pointing out that it was a trick question since there was no financial disclosure,  no one knows exactly what how or what President Trump benefits from financially. However, due to promises to abate lead in housing and to protect from LGBTQ discrimination in housing markets, Warren decided not to stand in Carson’s way. Coverage via The Hill.
  • President Trump’s pick for Secretary Treasury, Steve Mnuchin, lied during his confirmation hearing about foreclosure practices of One West Bank while he was the chairmen and CEO, according to the Columbus Dispatch.
  • As the population ages, housing needs change. Are we keeping up with the new demand? New York Times opinion piece on the housing needs of the elderly.
  • Bay Area housing prices are going down due to building boom, via the Business Journal.
  • The National Low Income Housing Coalition released a statement in opposition of the Local Zoning Decisions Protection Act of 2017.

Did we miss anything? Let us know!

Erin Fuse Brown on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week features Professor Erin C. Fuse Brown of Georgia State University’s College of Law. We discussed her fascinating work on the law & policy of consumer protection in health care, including the new article “Consumer Financial Protection in Health Care.”

Our discussion centered on surprise medical bills (including balance billing),“inscrutable price opacity,” and medical debt collection. This is a difficult area and one that implementers of the ACA have only begun to confront. Looking forward, our consensus was that this increasingly will become the province of “bifurcated” state laws passed under the specter of ERISA preemption–which could leave those in self-insured plans at the mercy of their employers.

For a thoughtful perspective on cutting edge efforts to protect patients from surprise bills and opaque billing, there is no better resource. And be sure to check out her SSRN Page for other important work on ongoing efforts to bend the cost curve in health care and assure more universal access to care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Trap for the Unwary Works Again: Federal Healthcare and the Limitations Provision of the Federal Tort Claims Act

By Alex Stein

The same story involving a federally qualified health center (FQHC) repeats itself again, again, and now again: see Phillips v. Generations Family Health Center, — Fed.Appx. —- (2016), 2016 WL 5340278 (2d Cir. 2016).

A patient from Connecticut receives medical treatment from a physician who works at a Connecticut-based facility known as Generations Family Health Center. This center is an FQHC and the physician is consequently deemed a federal employee pursuant to 42 U.S.C. § 233(g)-(n) (as explained, inter alia, in Phillips v. Generations Family Health Center, 723 F.3d 144, 145 (2d Cir. 2013)). The patient is unaware of this fact even though she could easily find it on the center’s website and in this database that belongs to the Department of Health and Human Services (DHHS). Subsequently, when the patient suspects that her physician committed malpractice, she and her attorney sue him in a Connecticut court because they believe him to be just a regular doctor from Connecticut. Alas, they could only sue the physician according to the Federal Tort Claims Act (FTCA) after going through a mandatory administrative claim process at DHHS. 28 U.S. Code §§ 1346 (b)(1), 2675. When they realize it, the suit becomes time-barred pursuant to the FTCA, 28 U.S. Code § 2401 (b) (“A tort claim against the United States shall be forever barred unless it is presented in writing to the appropriate Federal agency within two years after such claim accrues or unless action is begun within six months after the date of mailing, by certified or registered mail, of notice of final denial of the claim by the agency to which it was presented.”). Continue reading

REGISTER NOW (2/10)! Returning Results to Research Participants: A Health Policy and Bioethics Consortium

health-policy-and-bioethics-consortium-visixREGISTER NOW! Returning Results to Research Participants: A Health Policy and Bioethics Consortium

February 10, 2017 12:30 – 2:00 PM
Wasserstein Hall, Milstein East C (2036)
Harvard Law School, Cambridge, MA

Register Now!

Clinical investigators, public health advocates, and IRBs have been struggling to develop appropriate policies on how to return results to patients involved in research studies. These results may come in a variety of forms, ranging from aggregated study results to individual results to incidental findings. Experts disagree over the optimal timing, how researchers should consider the burden that these results can place on patients, and whether there are circumstances in which certain findings should be withheld. Is clinical utility the appropriate standard, or does mere curiosity suffice to trigger disclosure obligations? How certain must the results be, and what if there is reason to believe that the results will be difficult for participants to understand – or cause them harm?  Two experts in the field of research law and ethics will join us to engage these and other questions, and help conceive a way to move forward in the best interests of patients and the medical research enterprise. Continue reading

Artificial Intelligence, Medical Malpractice, and the End of Defensive Medicine

Artificial intelligence and machine-learning algorithms are the centerpieces of many exciting technologies currently in development. From self-driving Teslas to in-home assistants such as Amazon’s Alexa or Google Home, AI is swiftly becoming the hot new focus of the tech industry. Even those outside Silicon Valley have taken notice — Harvard’s Berkman Klein Center and the MIT Media Lab are collaborating on a $27 million fund to ensure that AI develops in an ethical, socially responsible way. One area in which machine learning and artificial intelligence are poised to make a substantial impact is health care diagnosis and decision-making. As Nicholson Price notes in his piece Black Box Medicine, Medicine “already does and increasingly will use the combination of large-scale high-quality datasets with sophisticated predictive algorithms to identify and use implicit, complex connections between multiple patient characteristics.” These connections will allow doctors to increase the precision and accuracy of their diagnoses and decisions, identifying and treating illnesses better than ever before.

As it improves, the introduction of AI to medical diagnosis and decision-making has the potential to greatly reduce the number of medical errors and misdiagnoses — and allow diagnosis based on physiological relationships we don’t even know exist. As Price notes, “a large, rich dataset and machine learning techniques enable many predictions based on complex connections between patient characteristics and expected treatment results without explicitly identifying or understanding those connections.” However, by shifting pieces of the decision-making process to an algorithm, increased reliance on artificial intelligence and machine learning could complicate potential malpractice claims when doctors pursue improper treatment as the result of an algorithm error. In it’s simplest form, the medical malpractice regime in the United States is a professional tort system that holds physicians liable when the care they provide to patients deviates from accepted standards so much as to constitute negligence or recklessness. The system has evolved around the conception of the physician as the trusted expert, and presumes for the most part that the diagnosing or treating physician is entirely responsible for her decisions — and thus responsible if the care provided is negligent or reckless. Continue reading

CMS Publishes Final Rule Revising and Expanding Conditions for HHA Participation in Medicare and Medicaid

By Wendy S. Salkin

The Centers for Medicare and Medicaid Services (CMS) finalized a rule concerning home health agencies on January 9th, “Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies.” The rule has been a long time coming, since the proposed rules were set forth on October 9, 2014. This is the first time that CMS has successfully updated the home health agency (HHA) conditions of participation (CoPs) since 1989.

The aim of the final rule, according to CMS, is to “improve the quality of health care services for Medicare and Medicaid patients and strengthen patients’ rights.” The final rule

revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements.

According to CMS,

[t]hese changes are an integral part of [the Agency’s] overall effort to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

As is likely well known to readers, the use of home health services in the United States is widespread. According to the National Center for Health Statistics, as of 2014, there were 12,400 home health agencies in the United States and, during 2013, 4.9 million patients in the United States received and ended care from home healthcare workers. These numbers have since risen, and today in the United States there are nearly 12,600 Medicare and Medicaid-participating home health agencies and more than 5 million patients. Home health care serves a wide range of purposes. The Medicare website touts it as “usually less expensive, more convenient, and just as effective as care you get in a hospital or skilled nursing facility (SNF).” In addition to serving the aims of treating illness or injury, according to Medicare home health care “helps [patients] get better, regain [their] independence, and become as self-sufficient as possible.” Some examples of what home health care providers do with and for patients, upon doctor’s orders, include: wound care, patient and caregiver education, intravenous or nutrition therapy, injections, monitoring patient health condition, monitoring patient drug and treatment use, teaching patients how to care for themselves, and coordinating care between the patient, their doctor, and any other caregivers. Continue reading

National Survey Suggests that Off-Label Status is Material to Informed Consent

As many readers of this blog know, the FDA requires that, prior to entering the market, companies prove safety and efficacy for each intended use of their products, but physicians are then free to prescribe the products for any other uses.  (Companies are not allowed to promote off-label uses however.)

A recent national survey by Consumer Reports includes two interesting findings:

  1. About two-thirds (63%) of Americans “would not take a doctor prescribed medication that has been approved by the FDA, but not for their specific condition.”
  2. Almost all Americans (94%) “say they have never been told by a physician that a medication they were taking was not approved by the FDA for their condition.”

Patients are right to be skeptical of off-label uses, though they may not appreciate just how common they are.  In fact, most off-label use is unsupported by scientific evidence as to safety and efficacy.  A new report by the FDA illustrates several off-label uses that were subjected to rigorous clinical trials and turned out to be ineffective or dangerous.   For example, Aliskiren is approved for treatment of hypertension and was used off-label for prevention of congestive heart failure (CHF) complications.  A large trial showed that, although it did not significantly improve CHF mortality, it did significantly increase rates of kidney failure for CHF patients.  We do not know how many other off-label uses would fail if similarly tested.   Continue reading

An Alternative Point of View: The Societal Benefits of the Amgen v. Regeneron Injunction

Special Guest Post by Beau H. Miller, Jefferies

This article was originally published as part of research issued by the Jefferies Biotechnology Equity Research group.

Since the Amgen v. Regeneron ruling that resulted in Judge Robinson of the District Court of Delaware granting a permanent injunction removing Regeneron’s Praluent from the market (pending appeal), there have been a number of media and twitter commentaries providing their insights on the case.

These reactions have overall been of the opinion that it is a “shocking” precedent for a judge to remove an FDA-approved drug from the market for patent infringement – a remedy which patent owners, even pharmaceutical manufacturers, are justly able to obtain under the circumstances outlined in eBay v. MercExchange.

Given this, there are a few facts that have been overlooked in these reviews that lead us to disagree with some of the conclusions they reach, and also which led us to anticipate an injunction in this case. Continue reading

Looking Forward: The Next Generation of Biosimilars

Looking Forward: The Next Generation of Bio
similars

February 7, 2017 12:00 PM

Description

Many of today’s important medications are biological products made from living organisms, manufactured through biotechnology, derived from natural sources, or produced synthetically. Biosimilars are a type of biological product approved by FDA on the basis of being highly similar to an already approved biological reference product, like a generic drug.

This panel of experts will discuss the current state of biosimilars in the healthcare ecosystem and what comes next from a technical and legal perspective. Topics include how the next generation of biosimilars can improve patient access to standard-of-care therapies, the concept of “biobetters,” economic and intellectual property considerations, and policy approaches to support existing and future biosimilars.

Panelists

This event is free and open to the public. Lunch will be provided.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

What is the Meaning of Trump’s Day 1 Executive Order on the ACA?

Guest Post by Erin C. Fuse Brown

On the day of his inauguration, President Trump signed an executive order instructing the executive branch agencies to exercise their discretion and authority to  “waive, defer, grant exemptions from, or delay the implementation of” fees, taxes, or penalties under the Affordable Care Act (ACA).

The order does not specify which “fiscal burdens” it targets, but the individual mandate, the employer mandate, and the various industry and payroll taxes imposed by the law immediately jump to mind. These are all written into the law, and the President cannot unilaterally set them aside. The executive order says it is following the law, including the Administrative Procedure Act, which is good because it means the President is not instructing anyone to flout the law. Even existing ACA rules cannot be undone overnight and can only be changed or repealed through a lengthy notice-and-comment rulemaking process.

There is such a thing as “enforcement discretion,” which some suggest means that the individual mandate won’t be enforced anymore. I’m not so sure. If the President instructed the IRS to stop collecting taxes from billionaires under its enforcement discretion, that wouldn’t be legal. Continue reading

Digital Health @ Harvard Brown Bag Lunch Series: Free Independent Health Records, featuring Adrian Gropper, MD

January 26, 2017 12:00 PM
Berkman Klein Center for Internet and Society
23 Everett St., 2nd floor, Harvard Law School, Cambridge, MA

Register for this event

The Digital Health @ Harvard brown bag lunch series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology. The series is cosponsored by the Berkman Klein Center for Internet & Society at Harvard University and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. The goal of the series is to discuss ongoing research in this research area, share new developments, identify opportunities for collaboration, and explore the digital health ecosystem more generally.

These lunches are free and open to the public, but RSVPs are required. RSVP now!

This Month

Dr. Adrian Gropper is working to put patients in charge of their health records, arguably the most valuable and most personal kinds of connected information about a person. They encompass elements of anonymous, pseudonymous, and verified identity and they interact with both regulated institutions and licensed professionals. Gropper’s research centers on self-sovereign technology for management of personal information both in control of the individual and as hosted or curated by others. The HIE of One project is a free software reference implementation and currently the only standards-based patient-centered record. The work implements a self-sovereign UMA Authorization Server and is adding blockchain identity as self-sovereign technology to enable licensed practitioners to authenticate and, for example, write a compliant prescription directly into the patient’s self-sovereign health record. Continue reading