Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data

The Cleveland Clinic’s Roger Klein responds to my previous GLR post:

Roger-Klein-MD-JDThe Office of Civil Rights’ interpretation of the requirements of 45 CFR § 164 could pose problems for clinical laboratories and the professionals who practice within them. Although the issue of providing benign variants for a single gene, at least prospectively, would be straightforward, a broad definition of the designated medical record set could result in considerable complexity when one considers large-scale sequencing. Some excluded data can be of variable reliability, may be prospectively filtered by software, or may otherwise be omitted from the patient report because of professional interpretation and judgment. One can legitimately argue that this interpretation and judgment, as reflected in the patient report, should serve as the gateway to the official medical record.
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Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society

UNC Geneticist Comments on Testing Laboratories’ Duty to Return Genomic Data to Patients

UNC’s Karen Weck responds to my previous GLR post:

I agree in principle that patients have the right to access their genomic data; however, in practice it is much more complicated (as things often are). Giving a patient his/her raw sequencing data would be meaningless – it is the interpretation of the clinical significance of sequence data that is important when reporting results. This latter requires the expertise of molecular genetic laboratorians and clinical geneticists. We do not return all genomic sequence variants to individuals in exome sequencing, for example when we determine that they are unlikely to be contributory to their disease or medical health. It is important to those of us doing this that we retain the ability to use our professional judgement to determine what should be reported to patients as medically relevant, primarily so as not to dilute important medical information with irrelevant information.

Karen E. Weck, MD
Professor of Pathology & Laboratory Medicine and Genetics
Director, Molecular Genetics
University of North Carolina at Chapel Hill

Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Society

ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance

MyriadJust about everyone interested enough in genomics and the law to read this post will know that the American Civil Liberties Union waged a long and ultimately successful legal campaign to invalidate Myriad Genetics’ patent claims to isolated BRCA genes, mutations of which are linked to breast and ovarian cancer. Now the ACLU has launched a second front, this time attacking Myriad’s post-patent business model of maintaining its vast and unique database of genotype-phenotype associations as a trade secret. GLR reported on that evolving strategy two years ago.

The new ACLU attack has, thus far, received modest attention in the scientific press, and some of what has been reported is inaccurate. In this post I will briefly review what has actually happened and then try to sort out fact from fiction in the reportage. The bottom line is that the federal government has not created new stealth regulations dealing with the disclosure of genomic data to patients. It has, however, used the practice of governance-by-guidance to make significant new policy, which is problematic enough in its own right.
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Filed under Genomic Policymaking, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation

Recent Developments in European Law with Implications for the U.S. Life Sciences Industry

Safe HarborThe last several months have seen several developments in European privacy and intellectual property that have significant implications for life sciences interests—both commercial and academic—in this country. Here is a brief review:

1. Final Approval of Pending EU General Data Protection Regulation

On April 14, 2016, the Parliament of the European Union gave final approval to the long-discussed GDPR. It will replace the current regime of country-by-country laws under the 1995 Data Protection Directive. Whereas an EU Directive requires implementation by individual EU member states, the GDPR is a Regulation (much like a federal law in this country) that will take immediate effect in all EU countries in the spring of 2018.
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Filed under General Interest, International Developments, Legal & Regulatory, Pending Regulation, Privacy, Privacy, Privacy

How Privacy Law Affects Medical and Scientific Research

eyeball_nOver the last five or so years my law practice has focused increasingly on privacy law, both domestic and international. In hindsight, this was a predictable outcome: as an intellectual property lawyer, many of my clients do business on the Internet or are engaged in scientific research and development, with many of the latter in the health care area. These are the very kinds of people who need to worry about privacy—of their customers, users, patients, and subjects. As they started on focusing on privacy concerns, these clients turned to their IP lawyers for help, and my Robinson Bradshaw colleagues and I have tried to stay ahead of their needs.

As a consequence of my growing privacy practice, I am regularly called on to give overviews to other lawyers as well as non-lawyers in the scientific and business communities. I thought it might be useful to devote a GLR post to a privacy law summary targeted at readers who conduct medical and other scientific research. Privacy law is a transnational mess, so this will be a bit longer than I’d like—my apologies, and please don’t shoot the messenger—but I’ll try to cut through the legal jargon.
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Filed under International Developments, Legal & Regulatory, Privacy

Are Software Patents Dead?—Alice’s Implications for Life Sciences

Not too long ago, getting patents on software and business methods was all the rage. And concern about their effects was profound. In fact, in 2003 I spoke at a Federal Reserve Bank conference devoted to the question of whether such patents were an existential threat to the financial industry. Now, after a series of Supreme Court cases that brought about a dramatic shift in the approach taken by the lower courts and the Patent Office, the question is whether those patents are still alive. The answer is that they are, but barely, and their prognosis is bad.

Do these developments matter to people in the life sciences? The answer is a resounding yes. If we then ask why software patentability matters, the answer is that life sciences are increasingly focused on software-dependent data analysis.

These points were brought home to me when I spoke at another, more recent conference—the Bio-IT World Conference in Boston this past April.
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Filed under Bioinformatics/IT, Industry News, Legal & Regulatory, Patent Litigation, Patents & IP

Conley Q & A on LDTs and the FDA

FDA v LDTIn her recent post on the FDA’s draft guidance on its proposed oversight of Laboratory Developed Tests (LDTs), Jen Wagner mentioned my interview with Genome Web’s Turna Ray on January 15, 2015. Turna asked me to address some arguments made in a “white paper” written by former U.S. Solicitor General Paul Clement and Harvard law professor Laurence Tribe on behalf of their client, the American Clinical Laboratory Association. The main point that Clement and Tribe made was that the FDA lacks legal authority to oversee LDTs, at least in the way that it’s proposing to do so. As I told Turna, I don’t necessarily disagree with their position; in fact, I’m skeptical about the FDA’s authority to do this. Also, like Jen, I’m not persuaded the proposed FDA initiative is likely to work well from a practical perspective. Nonetheless, I agreed to play along in a devil’s advocate exercise, making the counterarguments I’d make if representing the FDA. Here’s a brief summary of my arguments:
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Filed under Badges, FDA LDT Regulation, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Legal & Regulatory, Pending Regulation, Uncategorized

Medical Organizations Can’t Shape the Rules for Admitting Expert Testimony

96-well plateA little more than a year ago I wrote a post about the then-new Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing from the American College of Medical Genetics and Genomics (ACMG). Those Recommendations (since modified somewhat) proposed that whenever a patient undergoes whole-genome or whole-exome sequencing (WES) for any purpose, the laboratory doing the testing should always sequence and report to the ordering physician the results for 57 (now 56) genes on the ACMG’s list. Among the questions I addressed in that post was this one: “Do those Recommendations become by definition the standard of care for the specialty, immediately or in the near future?” I wondered specifically about a future case in which a doctor ordered WES, the lab analyzed only the genes the doctor was interested in, leaving out some of the ACMG’s 56, and the patient subsequently suffered a bad medical outcome linked to an omitted gene. Would failure to follow the ACMG Recommendation be evidence—maybe even conclusive evidence—of malpractice?
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Filed under Genetic Testing/Screening, Genomics & Medicine

New Article on Myriad Litigation and the Company’s Evolving Strategy

MyriadGLR editor John Conley has just co-authored a new article in the North Carolina Journal of law & Technology about Myriad Genetics’ response to last summer’s Supreme Court case that invalidated its broadest gene patents. The article focuses on Myriad’s business decision to rely less on patents and more on its vast proprietary database, especially in its growing European operations. The co-authors are Robert Cook-Deegan, M.D., a research professor of public policy and medicine at Duke, and Gabriel Lazaro-Munoz, J.D., Ph.D., a post-doctoral fellow at UNC’s Center for Genomics and Society (where John is also an investigator). The article was included in NC JOLT’s 2014 Symposium, “Gene Patents After Myriad.” The Symposium also includes articles by Sandra Park of the ACLU, who was involved in the Supreme Court case, and law professors Lori Andrews and Christopher Holman. The Symposium can be accessed at Here are links to the full Conley, Cook-Deegan and Lazaro-Munoz article the abstract (NC JOLT is Open Access):
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Filed under Uncategorized

ACMG Backs Down a Bit

57 sauceA year ago, the American College of Medical Genetics and Genomics (ACMG) released its Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. As I reported in a July 2013 post, the core recommendation was this: “The ACMG recommends that for any evaluation of clinical sequencing results, all of the genes and types of variants in the Table should be examined and the results reported to the ordering physician.” Specifically, the ACMG recommended that whenever a lab does whole genome or whole exome sequencing on a patient, it should examine all 57 [now 56] genes on the list included in the Recommendations and report any clinically significant findings to the ordering physician. It would then be the duty of that physician “to provide comprehensive pre- and post-test counseling to the patient.” Most controversially, the ACMG recommended that the test findings “be reported without seeking preferences from the patient and family and without limitation due to the patient’s age.” As I characterized it in the July post, “patients should be given the 57-gene screening whether they want it or not and told the results even if they say they don’t want them.”
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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Informed Consent