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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Filed under Biobanking, General Interest, Genomics & Medicine, Industry News, Legal & Regulatory, Pending Litigation, Privacy

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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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, International Developments, International News, Legal & Regulatory, Patents & IP, Pending Litigation, Privacy

Prometheus Returns to the Supreme Court, Medical Method Patent Speculation Intensifies

While everyone has been busy speculating about whether the Supreme Court will ultimately take the Myriad case, the justices (at least four of them—see below) sprung a surprise this week by deciding to review the Federal Circuit’s decision in another biomedical patent case, Prometheus v. Mayo.

The patents at issue in Prometheus involve a method of administering a drug (specifically thiopurine drugs used to treat gastrointestinal and other autoimmune diseases), measuring the drug’s level in a patient’s body, and then adjusting the dosage of the drug. The Supreme Court will hear the case this fall and should (see below) issue a ruling by next summer, thus drawing to a close a legal journey that began more than three years ago in a California district court.


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Filed under Genetic Testing/Screening, Genomic Policymaking, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Update: Proposed Second Opinion Safe Harbor for Genetic Diagnostic Testing Withdrawn

We reported yesterday on a proposed Patent Act amendment that, if successful, would create a safe harbor for second opinion genetic diagnostic testing. While conceptually simple, the proposed amendment would have left genetic testing developers and providers, patent holders and courts with considerable uncertainty about the safe harbor’s appropriate interpretation and application.

Initially offered by Representative Debbie Wasserman Schultz (D-FL) in April, the amendment surfaced again this past week in the Manager’s Amendment to H.R. 1249 (pdf), the House’s attempt at patent reform legislation.

As news of the proposed amendment spread, it generated a flurry of activity on Capitol Hill. The American Civil Liberties Union (ACLU), the group largely responsible for coordinating the plaintiffs in the Myriad gene patent litigation, spearheaded the charge. An ACLU-led coalition wrote in opposition to the proposed amendment (pdf), arguing that the proposed second opinion safe harbor “would fail to block all patent holder objections to [second opinion] testing, fails to address the many other limitations on scientific research arising out of the issuance of [gene patents], and risks allowing gene patent holders to argue that Congress implicitly endorses the validity of such patents.” The group was joined in its efforts by the American Medical Association, the Association for Molecular Pathology (the first named plaintiff in Myriad) and others, who collectively lobbied Rep. Wasserman Schultz and her colleagues to avoid creating “unintended harms to patients, medical professionals and genetic researchers.”


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Regulation

DTC Genetic Testing and the FDA: is there an end in sight to the regulatory uncertainty?

Editor’s Note: This was first published at Genomes Unzipped and was co-authored by Daniel MacArthur and Luke Jostins. Genomes Unzipped received 12 free kits from Lumigenix for review purposes, and Dan Vorhaus has provided legal advice to the company. Genomes Unzipped plans to release a full review of the Lumigenix service in early July.

Last month three direct-to-consumer (DTC) genetic testing companies opened their mailboxes to find a slightly ominous but entirely expected letter from the FDA. The three recipients (LumigenixAmerican International Biotechnology Services and Precision Quality DNA) received substantively equivalent letters, with the FDA warning each company that its genetic testing service “appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act,” and that the agency would like to meet with company representatives “to discuss whether the service [they] are promoting requires review by FDA and what information [they] would need to submit in order for [their] product to be legally marketed.”


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Filed under Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation

House Introduces Patent Reform Proposal to Permit Second Opinions in Genetic Diagnostic Testing

When we last checked in on the state of patent reform back in March, the Senate had just passed the America Invents Act (S.23) or, as it is more commonly known, the Patent Reform Act of 2011 (pdf) by an overwhelming 95-5 vote.

Following its passage in the Senate, the legislation promptly stalled in the House of Representatives and, several months and numerous committee hearings later, that is where it remains. Fierce lobbying and political maneuvering have thrown multiple key provisions of the reform legislation into doubt. Leading areas of debate include the constitutionality of a proposed change from a “first-to-invent” to a “first-to-file” patent system and a provision that would allow the patent office to retain user fees to fund its own operations.

While it remains unclear whether patent reform will actually occur, the latest round of legislative wrangling has introduced one proposal of particular interest to Genomics Law Report readers. Among 86 pages of proposed amendments (pdf) to H.R.1249 (the House version of the patent reform legislation) offered earlier this week is a provision that, if adopted, would provide an infringement safe harbor for second opinion genetic diagnostic testing.

Permitting Second Opinions in Certain Genetic Diagnostic Testing. Introduced as part of the Manager’s Amendment (pdf) submitted by Representative Lamar Smith (R-TX), the proposal is conceptually simple. It would create a new Section 287(d) under the Patent Act to establish a safe harbor for second opinion genetic diagnostic testing providers, much like the safe harbor that already exists at Section 287(c) for medical practitioners’ performance of medical activities.


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Regulation

News Roundup: Perception Gaps and Progress in Personalized Medicine

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.

Personalized Medicine’s Perception Gaps. A new report released this week by the biopharmaceuticals company Quintiles (pdf) examines the perspectives of four key stakeholder groups – biopharma executives (n=200), managed care executives (n=153), physicians (n=503) and patients (n=1,000) – across a wide range of personalized medicine issues.

The report contains a number of interesting statistical nuggets about how these groups perceive their strengths, weaknesses and future role in the advancement of personalized medicine. These include the following:


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Filed under General Interest, Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News

Updating the DTC Debate: Trial by Press Release, More FDA Letters, the Problem of Pleiotropy and New RUO Guidance

Later today I will join several colleagues here in Chicago, IL at the American Society of Clinical Oncology (ASCO) annual meeting for a panel discussion on Direct-to-Consumer Genetic Testing for Cancer: What Physicians Need to Know (pdf). (Daniel MacArthur and Misha Angrist will not be on the panel, although each joined us in authoring the pre-conference paper.)

This will, I believe, mark direct-to-consumer (DTC) genetic testing’s formal debut at ASCO. It should also serve as another reminder that, despite its relatively small numbers (both in terms of dollars and customers), DTC genetic testing continues to exert an outsized influence when it comes to conversations about the future of genomic medicine. This is particularly true when the discussion turns to appropriate policy and regulatory oversight.

In advance of ASCO, here are several items of interest from the past few weeks in DTC genetic testing.


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Filed under Direct-to-Consumer Services, FDA LDT Regulation, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation