The $4 billion Medical Data Breach Case That Lost Its Way

By Nicolas Terry

Sutter Health v. Superior Court, 2014 WL 3589699 (Cal. App. 2014), is a medical data breach class action case that raises questions beyond the specifics of the Californian Confidentiality of Medical Information Act.

The stakes were high in Sutter — under the California statute medical data breach claims trigger (or should trigger!) nominal damages at $1000 per patient. Here four million records were stolen.

Plaintiffs’ first argued the defendant breached a section prohibiting unconsented-to disclosure. The not unreasonable response from the court was that this provision required an affirmative act of disclosure by the defendant which was not satisfied by a theft.

A second statutory provision argued by the plaintiffs looked like a winner. This section provided, “Every provider of health care … who creates, maintains, preserves, stores, abandons, destroys, or disposes of medical information shall do so in a manner that preserves the confidentiality of the information contained therein.” Read More

Art Caplan Says Vasectomy Has No Place in Plea Deal

Art Caplan has a new opinion piece on NBCNews on the controversy over the case of Jessie Herald, in which he was offered a plea bargain that involved sterilization for a reduced sentencing. From the piece:

Jessie Lee Herald was facing five years or more in prison after a crash in which police and prosecutors said his 3-year-old son was bloodied but not seriously hurt. But Herald cut a deal. Or more accurately, the state agreed to reduce his sentence if he would agree to be cut. Shenandoah County assistant prosecutor Ilona White said she offered Herald, 27, of Edinburg, Virginia, the opportunity to get a drastically reduced sentence if he would agree to a vasectomy. It may not be immediately clear what a vasectomy has to do with driving dangerously and recklessly. It shouldn’t be. There is no connection.

Read the full article.

Chip and Fish: Inadvertent Spies

Art Caplan has authored a new opinion piece on Bioethics.net on the issue of “chipping” human beings. From the piece:

There has been a great deal of fingerpointing, second-guessing and recrimination over the decision by the President to exchange five former Taliban leaders for the American soldier, Bowe Bergdahl.  “You’ve just released five extremely dangerous people, who in my opinion … will rejoin the battlefield,” Senator Marco Rubio, R-Fla., and likely Presidential candidate told Fox News.  Senator John McCain, R-AZ, told ABC news and many other outlets that he would never have supported the swap if he’d known exactly which prisoners would be exchanged given their former high roles in battling the U.S. in Afghanistan.

Put aside for a second whether the five Taliban leaders that were flown to Qatar for Bergdahl are now too old and too long removed from Taliban affairs to resume anything close to their old roles.  Presume, instead, they will eagerly resume where they left off prior to their capture, attacking Americans and others they see as hindering Taliban goals for Afghanistan.  Is it possible that the U.S. did something to these men before letting them go in the swap—surreptitiously implanting them with microchips so that they could be tracked or traced?

Read the full article.

PCAST, Big Data, and Privacy

By Leslie Francis

Cross-post from HealthLawProf Blog

The President’s Council of Advisors on Science and Technology (PCAST) has issued a report intended to be a technological complement to the recent White House report on big data. This PCAST report, however, is far more than a technological analysis—although as a description of technological developments it is wonderfully accessible, clear and informative.  It also contains policy recommendations of sweeping significance about how technology should be used and developed.  PCAST’s recommendations carry the imprimatur of scientific expertise—and lawyers interested in health policy should be alert to the normative approach of PCAST to big data.

Here, in PCAST’s own words, is the basic approach: “In light of the continuing proliferation of ways to collect and use information about people, PCAST recommends that policy focus primarily on whether specific uses of information about people affect privacy adversely. It also recommends that policy focus on outcomes, on the “what” rather than the “how,” to avoid becoming obsolete as technology advances. The policy framework should accelerate the development and commercialization of technologies that can help to contain adverse impacts on privacy, including research into new technological options. By using technology more effectively, the Nation can lead internationally in making the most of big data’s benefits while limiting the concerns it poses for privacy. Finally, PCAST calls for efforts to assure that there is enough talent available with the expertise needed to develop and use big data in a privacy-sensitive way.”  In other words:  assume the importance of continuing to collect and analyze big data, identify potential harms and fixes on a case-by-case basis possibly after the fact, and enlist the help of the commercial sector to develop profitable privacy technologies.  Read More

Bumps on the Road Towards Clinical Trials Data Transparency- A recent U-Turn by the EMA?

By Timo Minssen

In a recent blog I discussed the benefits and potential draw-backs of a new “EU Regulation on clinical trials on medicinal products for human use,” which had been adopted by the European Parliament and Council in April 2014. Parallel to these legislative developments, the drug industry has responded with its own initiatives providing for varying degrees of transparency. But also medical authorities have been very active in developing their transparency policies.

In the US, the FDA proposed new rules which would require disclosure of masked and de-identified patient-level data. In the EU, the EMA organized during 2013 a series of meetings with its five advisory committees to devise a draft policy for proactive publication of and access to clinical-trial data. In June 2013 this process resulted in the publication, of a draft policy document titled “Publication and access to clinical-trial data” (EMA/240810/2013).

Following an invitation for public comments on this document, the EMA received more than 1,000 submissions from stakeholders. Based on these comments the EMA recently proposed “Terms of Use” (TOU) and “Redaction Principles” for clinical trial data disclosure.

In a letter to the EMA’s executive director Dr. Guido Rasi, dated 13 May 2014, the European Ombudsman, Emily O’Reilly, has now expressed concern about what seems to be a substantial shift of policy regarding clinical trial data transparency. Read More

Not Just Any Week in Privacy

By Nicolas Terry

Privacy is never easy to think about. This week it became harder. Two pieces framed my week. First, Eben Moglen’s essay in The Guardian (based on his Columbia talks from late last year) took my breath away; glorious writing and stunning breadth combined to deliver a desperately sad (but not entirely hopeless) message about government and corporate overreaching in data collection and processing.

A wry speech posted by software developer Maciej Ceglowski also helped frame my thoughts. He wrote, “The Internet somehow contrives to remember too much and too little at the same time, and it maps poorly on our concepts of how memory should work.” There’s the problem in a nut. Ceglowski alludes to the divide between how human (offline) memory operates (it’s “fuzzy” and “memories tend to fade with time, and we remember only the more salient events”) and the online default of remembering everything. Government and Google and, for that matter, Big Data Brokers tell us that online rules now apply across the board and ‘that’s just peachy’ because we’ll have better national security, better searches, or more relevant advertising. But, that’s backwards. Read More

DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Read More

A Bad Debt That Will Shake Big Data

By Nicolas Terry

A resident of Spain allegedly owed back taxes triggering attachment proceedings. The local newspaper published the details of an upcoming auction of his property in early 1998. At some point the issue was settled. However, the matter was not forgotten—the newspaper was online and a Google search of the gentleman’s name returned this history. He complained to the Spanish data protection agency (AEPD) that he had a right to have older, irrelevant information erased and that Google should remove the links. The AEPD agreed and Google sued for relief. The Spanish High Court referred the interpretation of the Data Directive (95/46) to the European Court of Justice in 2010 and in 2013 the Advocate-General issued an advisory opinion supportive of Google’s position. Somewhat surprisingly the European Court of Justice has now taken the opposite view (Case C‑131/12, Google Spain SL v. AEPD, May 13, 2014). Read More

Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:

  • Stem cell therapies
  • Nanotechnologies
  • Genetic (and biomarker) tests
  • Gene therapies
  • Personalized medicine
  • Comparative efficacy research
  • Drug resistant pathogens
  • Globalized markets
  • Tobacco
  • GMO
  • Bioterrorism countermeasures
  • Mobile health technologies
  • Health IT
  • Drug shortages
  • Other related topics

Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at dsr@fdli.org by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.

We will notify selected participants by the end of June.  Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ).  Publication decisions will be made based on usual FDLJ standards.

A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

By Timo Minssen

Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law:

“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”

Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.

These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).

Read More