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Access as Equity: Efforts to Use Telemedicine to Expand Abortion Access

By Oliver Kim

I’ve written here before about areas where technology could play a role in providing access to complicated, controversial healthcare services. Earlier this year, I presented a forthcoming paper co-authored with a colleague on how technology can be used to provide greater equity in women’s health and how the law is being used to encourage such advances or block them. Given the political battles over women’s health, it should be no surprise that technology’s role in abortion access is under increasing scrutiny from lawmakers.

A medication abortion involves a two-step regimen: the woman first takes mifepristone, generally in a clinical setting, and 24 to 48 hours later, she takes misoprostol, generally in the privacy of her home. Recent research, though, suggests that women may not need to take mifepristone in a clinical setting: the World Health Organization revised its guidelines on whether the medications require “close medical supervision,” and a recent op-ed in the New England Journal of Medicine called on the Food and Drug Administration to revise its restrictions on mifepristone.

Given these findings, abortion providers have recognized that telemedicine could be utilized to expand access into areas where abortion services are limited due to geography, legal restrictions, or both. Since 2008, Planned Parenthood in Iowa has used telemedicine to overcome both provider shortages and geographic challenges: a physician can use video conferencing services to appear virtually at health centers across the state, reviewing a patient’s ultrasound and medical history remotely and providing counseling over a secure, private system. The majority of the medical literature finds that using telemedicine to provide medication abortions is just as safe and effective as if a woman met with a clinician in person.

As we discuss in our paper, when technology expands access to care that is politically controversial, policymakers may use the law to restrict such technological advances. In response to this use of telemedicine, states hostile to abortion began passing bans. When Iowa’s medical board attempted to restrict such a use of telemedicine, the Iowa Supreme Court struck down the board’s regulation, holding that it would be an undue burden on a woman’s right to an abortion. Some hailed the Iowa decision as groundbreaking and hopefully influential on other state supreme courts. (Later that same year, the U.S. Supreme Court in Whole Woman’s Health would strike down two Texas statutory restrictions on abortion providers as undue burdens on a woman’s right to an abortion.)

What I find interesting—and what came out after we submitted our paper—is how telemedicine and abortion are being treated in neighboring Kansas and how it reflects the larger legal debate over these issues. In 2011, Kansas first attempted to ban telemedicine abortions by requiring a physician to be physically present when administering mifepristone, thus eliminating the value of telemedicine. Subsequently, the Kansas state legislature modified the ban in 2015 by clarifying that a physician would not need to be physically present in a medical emergency; in 2018, the legislature passed explicit language in the Kansas Telemedicine Act that nothing in this new telemedicine legislation authorized the use of telemedicine for abortion. However, a Kansas court enjoined the Kansas attorney general, the only defendant in this line of cases, from enforcing this provision or the in-person requirements under the court’s prior 2011 decision.

Even more remarkable, in the same state that elected Sam Brownback governor twice, the Kansas Supreme Court recently held in Hodes & Nauser v. Schmidt that the Kansas constitution provided a fundamental right to an abortion.

Thus, it may seem surprising that in a subsequent decision, a district court refused to grant a preliminary injunction for Trust Women, a Wichita-based abortion provider, to prohibit the state from enforcing the telemedicine abortion restrictions. Part of this new case turns on standing as well as recognizing that the prior line of telemedicine-abortion cases only enjoined the state attorney general and was silent on whether the state health department or county attorneys were similarly enjoined from enforcing the telemedicine-abortion bans.

Further, the court also turned part of its decision on whether Trust Women would suffer an irreparable injury: the court found that there was insufficient evidence of an injury because Trust Women still required patients to be present physically at its Wichita clinic in its telemedicine pilot, and Trust Women had taken no preliminary steps to open clinics in remote rural parts of the state. Indeed, the court decried the prior telemedicine-abortion rulings as “a growing procedural backwater” and suggested that the court needs to be able “to resolve the underlying merits of the telemedicine abortion issue,” necessitating that “the parties… present additional evidence and more probing legal analysis than has occurred at this early stage.”

While the district court has significant discretion in considering a request for a preliminary injunction, it does feel troubling that the court suggests that Trust Women should have invested time and resources into a telemedicine strategy that might be illegal before seeking relief. In light of the bans and the legislature’s hostility, it seems unlikely that Trust Women could have raised the funds necessary to create a telemedicine infrastructure and build clinics in remote rural areas. After all, although the Kansas Supreme Court’s decision was not on the telemedicine restrictions, it seems unlikely that they would survive a strict scrutiny review under Hodes since the state will bear the burden of justifying the law. Moreover, it’s also likely that the restrictions might not survive review under Whole Woman’s Health given the weight of medical evidence that suggests singling out abortion from all other services provided by telemedicine, is suspect.

This is also playing out on the national stage as the Fifth Circuit in June Medical v. Gee seemingly sent a direct challenge to Whole Woman’s Health where the Fifth Circuit upheld Louisiana abortion restrictions that were basically identical to the Texas restrictions that were struck down. How June Medical is ultimately resolved will have ramifications for telemedicine in this particular context.

While medical evidence demonstrates that telemedicine is a safe means of providing medication abortion (as well as providing other benefits for women such as privacy), there are of course those that dispute this notion. One could see a conservative court finding that a telemedicine ban is not an undue burden: under the Trust Women preliminary injunction ruling, women in rural areas are no worse off than they were before since they never had access to abortion via telemedicine to begin with. Further, if waiting periods and similar barriers are upheld post-Whole Woman’s Health, this could put rural access even further at risk. In other words, a woman still has access to abortion, just not via telemedicine. Of course many such arguments could be applied to any telemedicine application, so the question turns back again: Why place restrictions just on abortion services?

In so many areas, though, telemedicine has been hailed as a way to increase access for all patients. The issues arise in the same areas where there have always been strong opinions, but the evidence and the trend lines are overwhelmingly in favor of expanded telemedicine access. The law should follow.

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Nobody Reads the Terms and Conditions: A Digital Advanced Directive Might Be Our Solution

Could Facebook know your menstruation cycle?

In a recent Op-ed Piece, “You Just Clicked Yes. But, Do you Know Terms and Conditions of that Health App?,” I proposed that a mix of factors have given rise to the need to regulate web-based health services and apps. Since most of these applications do not fall under the Health Insurance Portability and Accountability Act (HIPAA), few people actually read through the Terms and Conditions, and also, the explosive growth of web-based health applications, the need for solutions is dire. Read More

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Data-driven Medicine Needs a New Profession: Health Information Counseling

By Barbara Prainsack, Alena Buyx, and Amelia Fiske

Have you ever clicked ‘I agree’ to share information about yourself on a health app on your smartphone? Wondered if the results of new therapy reported on a patient community website were accurate? Considered altering a medical device to better meet your own needs, but had doubts about how the changes might affect its function?

While these kinds of decisions are increasingly routine, there is no clear path for getting information on health-related devices, advice on what data to collect, how to evaluate medical information found online, or concerns one might have around data sharing on patient platforms.

It’s not only patients who are facing these questions in the age of big data in medicine. Clinicians are also increasingly confronted with diverse forms of molecular, genetic, lifestyle, and digital data, and often the quality, meaning, and actionability of this data is unclear.

The difficulties of interpreting unstructured data, such as symptom logs recorded on personal devices, add another layer of complexity for clinicians trying to decide which course of action would best meet their duty of beneficence and enable the best possible care for patients.

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Meditation? There’s an (almost FDA-approved) app for that

Headspace is paving the way for the first FDA-approved prescription meditation app.

Developers behind the mindfulness smartphone app, which has over 30 million users, are creating a new product under Headspace Health that will begin clinical trials this summer, in hopes of clearing FDA approval by 2020. The team is investigating how the app can help treat 12 mental and physical conditions.

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Emergent Medical Data

By Mason Marks

In this brief essay, I describe a new type of medical information that is not protected by existing privacy laws. I call it Emergent Medical Data (EMD) because at first glance, it has no relationship to your health. Companies can derive EMD from your seemingly benign Facebook posts, a list of videos you watched on YouTube, a credit card purchase, or the contents of your e-mail. A person reading the raw data would be unaware that it conveys any health information. Machine learning algorithms must first massage the data before its health-related properties emerge.

Unlike medical information obtained by healthcare providers, which is protected by the Health Information Portability and Accountability Act (HIPAA), EMD receives little to no legal protection. A common rationale for maintaining health data privacy is that it promotes full transparency between patients and physicians. HIPAA assures patients that the sensitive conversations they have with their doctors will remain confidential. The penalties for breaching confidentiality can be steep. In 2016, the Department of Health and Human Services recorded over $20 million in fines resulting from HIPAA violations. When companies mine for EMD, they are not bound by HIPAA or subject to these penalties.

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Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting

Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

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FitBits Be Free: General Wellness Products Are Not (Generally) Medical Devices

By Nicolas Terry

The FDA has issued a final guidance on low risk wellness devices, and it is refreshingly clear. Rather than applying regulatory discretion as we have seen in the medical app space, the agency has made a broader decision (all usual caveats about non-binding guidances aside) not to even examine large swathes of wellness products to determine whether they are Section 201(h) devices. As such, this guidance more closely resembles the 2013 guidance that declared Personal Sound Amplification Products (PSAPs) not to be medical devices (aka hearing aids).

The FDA approach to defining excluded products breaks no new ground. First, they must be intended for only general wellness use and, second, present a low risk. As to the former, FDA has evolved its approach to referencing specific diseases or conditions. Make no such reference and your product will sail through as a general wellness product. Thus, claims to promote relaxation, to boost self-esteem, to manage sleep patterns, etc., are clearly exempt. On the other hand, the agency will clearly regulate products that claim to treat or diagnose specific conditions. Read More

Legal Dimensions of Big Data in the Health and Life Sciences

By Timo Minssen

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

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Two Cheers for Corporate Experimentation

Rubin's vase2By Michelle Meyer

I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year’s terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was “When Companies Study Their Customers.”

This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).

Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Read More

Facebook Rumored To Be Planning Foray Into the Online Health Space

By Michelle Meyer

Reuters broke the story on Friday, citing anonymous sources:

The company is exploring creating online “support communities” that would connect Facebook users suffering from various ailments. . . . Recently, Facebook executives have come to realize that healthcare might work as a tool to increase engagement with the site. One catalyst: the unexpected success of Facebook’s “organ-donor status initiative,” introduced in 2012. The day that Facebook altered profile pages to allow members to specify their organ donor-status, 13,054 people registered to be organ donors online in the United States, a 21 fold increase over the daily average of 616 registrations . . . . Separately, Facebook product teams noticed that people with chronic ailments such as diabetes would search the social networking site for advice, said one former Facebook insider. In addition, the proliferation of patient networks such as PatientsLikeMe demonstrate that people are increasingly comfortable sharing symptoms and treatment experiences online. . . . Facebook may already have a few ideas to alleviate privacy concerns around its health initiatives. The company is considering rolling out its first health application quietly and under a different name, a source said.

I’m quoted in this International Business Times article about Facebook’s rumored plans. After the jump is the full statement I provided to the reporter (links added).  Read More