Category: Medical Privacy

The 21st Century Cures Act, HIPAA, Big Data, and Medical Research

W. Nicholson Price Leave a comment

By Nicholson Price

The 21st Century Cures Act is a big deal; the House passed it handily, and we’re still waiting to see what the Senate does.  A lot has been written about what it does in terms of changing FDA review processes, and a fair bit about the lovely increase in funding for NIH (see Rachel Sachs’ blog posts here, here, and here).  These are tremendously important.

But another provision in the bill has been getting much less play: the way it changes HIPAA to enable large-scale research, which is also a big deal all by itself. Read More

Should Health Lawyers Pay Attention To The Administration’s Privacy Bill?

Nicolas P. Terry Leave a comment

By Nicolas Terry

Cross Posted from Health Affairs Blog

Health care lawyers justifiably ignored the 2012 Obama administration consumer privacy framework because it expressly and broadly exempted entities subject to HIPAA, stating “To avoid creating duplicative regulatory burdens, the Administration supports exempting companies from consumer data privacy legislation to the extent that their activities are subject to existing Federal data privacy laws.”

In contrast, the administration’s 2015 draft bill, the Consumer Privacy Bill of Rights Act, though based on that framework, substantially affects health care entities, including those subject to HIPAA, and so demands more attention in the health law community.

The “HIPAA clause” in the draft bill is subtly different (and noticeably narrower than its preemption of state law clause): “If a covered entity is subject to a provision of this Act and a comparable provision of a Federal privacy or security law [the list includes HIPAA] such provision of this Act shall not apply to such person to the extent that such provision of Federal privacy or security law applies to such person.” Read More

Federal Newborn Screening Law Emphasizes Informed Consent

Michele Goodwin 4 Comments

By Allison M. Whelan (Guest Blogger)

On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs.  A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.

Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.

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A Chief Privacy Officer’s Take on the Chanko Case

laurenataylor 2 Comments

Earlier this month, Charles Ornstein explored a New York City family’s charge that their privacy was violated by a local hospital and a reality television show in ProPublica. More specifically, he details how the death of one Mr. Mark Chanko was filmed at NY Presbyterian Hospital without the family’s consent, and then nationally aired on ABC’s NY MED over a year later. Mr. Chanko’s face was blurred for viewers but he remained recognizable to family and friends who watched the show. Since the broadcast, the family has pursued legal action through several New York courts with little success thus far.

The piece has already been commented upon by several smart people, most recently Kay Lazar of the Boston Globe. Just one day after Ornstein’s piece went to press, the Dean of Harvard Medical School Jeffrey Flier (@jflier) tweeted “How could this be allowed to happen?” only to be informed by the Chair of Surgery at Boston Medical Center, Gerard Doherty, (@GerardDoherty4) that three Harvard-affiliated hospitals are in fact currently hosting camera crews for a similar series. The ensuing conversation reminded me just how limited a platform Twitter is for tricky conversations about health care law and ethics. So I did what any self-respecting millennial would do – I went home for the holidays and asked my mom to help me understand what the internet couldn’t.

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The Constitutional Implications of Ebola: Civil Liberties and Civil Rights In Times of Health Crises

Michele Goodwin Leave a comment

Join us for an important public forum:

Constitutional Implications of Ebola:
Civil Liberties & Civil Rights In Times of Health Crises

This public forum addresses the constitutional and public health implications of Ebola response in the United States.  According to state and federal laws, patient information is deemed private and is to be held in strict confidentiality.  However, in the wake of Ebola, well-established protocols to guard patient privacy have been neglected or suspended without public debate.  At this forum, a panel of experts raise questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy, civil liberties, and civil rights.  To what extent are Americans’ Ebola fears influenced by the origins of the disease?  What liberties are Americans willing to sacrifice to calm their fears?  How to balance the concern for public welfare with legal and ethical privacy principles?

Speakers: Reverend Jesse L. Jackson, Sr.;  Michele Goodwin, Chancellor’s Chair, UC Irvine School of Law;  Professor Andrew Noymer, UC Irvine School of Public Health; and Dr. George Woods, American Psychiatric Association.

This Forum intervenes in the current national and international discourse on Ebola by probing law’s role in addressing public health crises.  This forum is free and open to the public.

WHEN: Wednesday, November 19, 2014, 3.30pm-5.30pm

WHERE: University of California Irvine, School of Law; ROOM EDU 1111, 401 E Peltason Dr, Irvine, CA 92612

Ebola and Privacy

Michele Goodwin Leave a comment

By Michele Goodwin

As the nation braces for possibly more Ebola cases, civil liberties should be considered, including patient privacy.  As news media feature headline-grabbing stories about quarantines,  let’s think about the laws governing privacy in healthcare. Despite federal laws enacted to protect patient privacy, the Ebola scare brings the vulnerability of individuals and the regulations intended to help them into sharp relief.

In 1996, Congress enacted the Health Insurance Portability and Accountability Act (HIPAA) to protect patient privacy.  Specifically, HIPAA’s Privacy Rule requires that healthcare providers and their business associates restrict access to patients’ health care information.  For many years, the law has been regarded as the strongest federal statement regarding patient privacy. But it may be tested in the wake of the Ebola scare with patients’ names, photographs, and even family information entering the public sphere.

Ebola hysteria raises questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy.  What liberties are Americans willing to sacrifice to calm their fears?  How to balance the concern for public welfare with legal and ethical privacy principles?  For example, will Americans tolerate profiling travelers based on their race or national origin as precautionary measures?  What type of reporting norms should govern Ebola cases?  Should reporting the existence of an Ebola case also include disclosing the name of the patient?  I don’t think so, but the jury appears out for many.

Facebook Rumored To Be Planning Foray Into the Online Health Space

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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

HHS Issues Guidance on Same Sex Spouses and HIPAA

Leslie Francis Leave a comment

By Leslie Francis

[Cross-posted at HealthLawProfs blog.]

Under HIPAA, patients’ spouses and other family members have certain rights to access health information. In an important guidance document in the wake of United States v. Windsor, the Office for Civil Rights (OCR) at HHS has clarified that “spouse” under HIPAA refers to legally married same-sex spouses, even if the individual is receiving services in a jurisdiction not recognizing same-sex marriage.  Read More

Getting Granular with Apple’s mHealth Guidelines

The Petrie-Flom Center Staff Leave a comment

By Nicolas Terry

In a post last week I compared Apple’s new mHealth App store rules with our classic regulatory models. I noted that the ‘Health’ data aggregation app and other apps using the ‘HealthKit’ API that collected, stored or processed health data would seldom be subject to the HIPAA Privacy and Security rules. There will be exceptions, for example, apps linked to EMR data held by covered entities. Equally, the FTC will patrol the space looking for violations of privacy policies and most EMR and PHR apps will be subject to federal notification of breach regulations.

Apple has now publicly released its app store review guidelines for HealthKit and they make for an interesting read. First, it is disappointing that Apple has taken its cue from our dysfunctional health privacy laws and concentrated its regulation on data use, rather than collection. A prohibition on collecting user data other than for the primary purpose of the app would have been welcome. Second, apps using the framework cannot store user data in iCloud (which does not offer a BAA), begging the question where it will be acceptable for such data to be stored. Amazon Web Services? Third, while last week’s leaks are confirmed and there is a strong prohibition on using HealthKit data for advertising or other data-mining purposes, the official text has a squirrelly coda; “other than improving health, medical, and fitness management, or for the purpose of medical research.” This needs to be clarified, as does the choice architecture. Read More

Apple’s mHealth Rules Fear to Tread Where Our Privacy Laws Fall Short

Nicolas P. Terry Leave a comment

By Nicolas Terry

On September 9 Apple is hosting its ‘Wish We Could Say More’ event. In the interim we will be deluged with usually uninformed speculation about the new iPhone, an iWatch wearable, and who knows what else. What we do know, because Apple announced it back in June, is that iOS 8, Apple’s mobile operating system will include an App called ‘Health’ (backed by a ‘HealthKit’ API) that will aggregate health and fitness data from the iPhone’s own internal sensors, 3rd party wearables, and EMRs.

What has been less than clear is how the privacy of this data is to be protected. There is some low hanging legal fruit. For example, when Apple partners with the Mayo Clinic or EMR manufacturers to make EMR data available from covered entities they are squarely within the HIPAA Privacy and Security Rules triggering the requirements for Business Associate Agreements, etc.

But what of the health data being collected by the Apple health data aggregator or other apps that lies outside of protected HIPAA space? Fitness and health data picked up by apps and stored on the phone or on an app developer’s analytic cloud fails the HIPAA applicability test, yet may be as sensitive as anything stored on a hospital server (as I have argued elsewhere). HIPAA may not apply but this is not a completely unregulated area. The FTC is more aggressively policing the health data space and is paying particular attention to deviance from stated privacy policies by app developers. The FTC also enforces a narrow and oft-forgotten part of HIPAA that applies a breach notification rule to non-covered entity PHR vendors, some of whom no doubt will be selling their wares on the app store. Read More