Privacy

Courts in Unsettled Territory turn to the Map Available: United States v. Mitchell

We recently covered the Ninth Circuit’s split decision in Haskell v. Harris,1 which found DNA Fingerprinting of arrestees pursuant to California’s Prop 69 to be constitutionally sound. We also reported the Minnesota Supreme Court findings in In re Welfare of M.L.M. and State v. Johnson, rejecting challenges of DNA Fingerprinting based on 4th Amendment and Equal Protection grounds.

An Update from Colorado. An ongoing prosecution, United States v. Fricosu,2 became the most recent constitutional challenge to DNA fingerprinting upon arrest. The defendant, Ramona Fricosu, had her DNA sampled as part of her arrest pursuant to the DNA Fingerprinting Act of 2005, 42 U.S.C. §14135(a). She filed a motion challenging the constitutionality of the practice, requesting that the court order her DNA sample and CODIS profile be destroyed. Fricosu challenged the constitutionality of the practice on Fourth Amendment grounds. On February 22, 2012, Colorado District Judge Blackburn denied the motion (pdf).


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Ninth Circuit Issues Long-Awaited Ruling on Constitutionality of DNA Fingerprinting

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

In December 2009 the Northern District of California upheld the constitutionality of California’s Prop 69, which authorizes DNA fingerprinting as part of the routine booking process of individuals charged with felonies. There, in Haskell v. Brown, the defendants challenged California’s Prop 69 by arguing it violated both the 4th and 14th Amendments since, respectively, DNA fingerprinting upon felony arrest was, according to defendants, an unreasonable search and a violation of informational privacy.


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Minnesota the Latest to Weigh in on DNA Fingerprinting of Arrestees

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

There is an increasingly apparent absence of national consensus on whether the practice of collecting a DNA sample and creating a CODIS profile as part of the routine arrest booking procedures (i.e., “DNA fingerprinting”) conforms to the constitutional proscription of unreasonable searches and seizures articulated as the 4th Amendment. We mentioned this topic at the Genomics Law Report previously here, here, and here.

In July 2011, the 3rd Circuit upheld the federal DNA Fingerprinting Act of 20051 in United States v. Mitchell.2 Perhaps perceiving this ruling as a judicial green light, Pennsylvania’s General Assembly, as we recently noted, seems motivated to authorize the practice of DNA fingerprinting upon felony arrest. While the Pennsylvania Senate passed S.B. 775 and referred the matter to the House Judiciary Committee in December 2011, no apparent action has been taken on the measure since then.


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Alabama’s “Genetic Information Privacy Act” & the Ongoing Need for Personal Genomics Leadership

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.

Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.

A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).


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North Carolina One Step Closer to Compensating Victims of its Eugenics Program

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Almost a year ago, North Carolina Governor Bev Purdue set up a Task Force charged with determining how the state should compensate victims of its eugenics program. The Final Report (pdf) by that Task Force was submitted to the Governor on January 27, 2012. If the state legislature takes action to implement the Task Force’s recommendations, North Carolina will become the first state (of the 32 states that had eugenics programs) to compensate the victims of its involuntary sterilization program.


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Big Changes Coming in EU Privacy Law

The European Union is about to make major changes in its privacy law that will have a significant impact on U.S. companies that do even modest amounts of business in Europe. On January 25, 2011, the European Commission (the EU’s executive branch) released a long-awaited Draft Regulation on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data (pdf).

While it will likely be a year or more before a final regulation takes effect, and there will almost certainly be amendments along the way, American companies – including those involved in the field of personalized medicine, where personal data is paramount by definition – should start paying attention now, since they may have to change the way that they do business in Europe.


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Pennsylvania Seeks Expansion of its Forensic DNA Database

Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.

Last month, the Pennsylvania General Assembly voted in favor of a bill that would expand the Commonwealth’s criminal database. PA Senate Bill 775 authorizes law enforcement to begin DNA fingerprinting of individuals upon arrest or charge for certain specified crimes (as opposed to only upon conviction) and authorizes familial searching of the state’s forensic database. After third consideration, the amended version of PA Senate Bill 775 passed by a vote of 42-6. The bill has been referred to the judiciary.

The bill had been introduced in March of 2011 by Pennsylvania Senate Majority Leader Dominic Pileggio, who was later joined by a dozen colleagues (including nine Republican and three Democratic sponsors). It immediately garnered the attention of genetics law scholars, including Penn State Dickinson’s School of Law Professor David Kaye, who submitted a thorough statement (pdf) for the Pennsylvania General Assembly’s consideration.


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Don’t Forget About State Law: Michigan Decision Reminds Health Care Providers of HIPAA Preemption Issue

Phillip C. Ross is a summer associate at Robinson, Bradshaw & Hinson, P.A. and a rising third-year student at Wake Forest University School of Law.

Many health care providers and other individuals and entities who deal with sensitive patient information may assume that if they comply with the Health Insurance Portability and Accountability Act (“HIPAA”), they need not worry further about the proper use or disclosure of patient data. However, a recent Michigan Court of Appeals decision served as a reminder to those individuals and entities that they must not only ensure compliance with HIPAA, but also any state laws that are more demanding than HIPAA.

HIPAA establishes regulations for the use and disclosure of Protected Health Information (“PHI”) held by “covered entities” (pdf) and “business associates.” PHI is any information held by a covered entity related to health status, provision of health care, or payment for health care that can be linked to an individual.

In Isidore Steiner, DPM, PC v. Marc Bonanni, No. 294016 (Mich. Ct. App. Apr. 7, 2011), the Michigan Court of Appeals held that HIPAA acts as a federal “floor” in establishing standards for the privacy of patients’ PHI. Although Bonanni was decided under Michigan law—and thus is not binding on other states—the decision is likely to be consistent among courts in other states.


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News Roundup: Patent Reform Passes House, Human Provenance Project Pulled by UK

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the recent tweets from @genomicslawyer.

Patent Reform Legislation Passes House. Several months after the U.S. Senate passed patent reform legislation that would make sweeping changes to America’ patent system, including a switch from a first-to-invent to a first-to-file system for awarding patents, the U.S. House of Representatives finally followed suit yesterday, passing a similar piece of legislation by a vote of 304-117. The version passed by the House, while similar to that passed by the Senate, contained a number of last-minute amendments (pdf).

One change of particular relevance to the personalized medicine community was the removal of a proposed safe harbor for second opinion genetic diagnostic testing, which was replaced by a requirement that the U.S. Patent and Trademark Office (USPTO) investigate the relationship between genetic diagnostic tests, gene patents and exclusive licenses. The USPTO would be given nine months to complete its investigation and to return to Congress recommendations for ensuring the availability of second opinion genetic diagnostic testing. (The USPTO study on genetic diagnostic testing was not included in the bill passed by the Senate in March.)


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Is the Genetic Rights Movement Picking Up Steam?

The movement to confer greater legal protection to individuals’ genetic information has added another participant. Last month, we examined newly introduced legislation in Massachusetts which, if passed, would create a “Genetic Bill of Rights,” significantly expanding Massachusetts residents’ personal property and privacy rights in their genetic information. Since then, in what the Council for Responsible Genetics has termed a “groundswell for genetic privacy building in states,” state legislators in both California and Vermont have introduced new legislation that would confer greater protection upon individuals’ genetic information.

What should we make of this three state “groundswell?” Although not identical in scope or substance to the Massachusetts Genetic Bill of Rights (“MA GBR”), both the Vermont and California proposals appear to reflect a concern (shared by the MA GBR) that, at least when it comes to the use and misuse of genetic information, the current system of federal oversight is inadequate. Then again, as the legislative findings section of the California proposal (pdf) puts it, perhaps “the current explosion in the science of genetics” simply “compels legislative action in this area.”


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