Robinson Bradshaw

Topic: FTC

LabMD Update

Last September, I reported on the Federal Trade Commission’s decision upholding its enforcement action against the now-defunct clinical laboratory LabMD, Inc. In 2013, the FTC brought an administrative complaint against LabMD, alleging that its lax cybersecurity practices resulted in the exposure of patient data. As I wrote last year, exposure was the key word, as […]

FTC Muscles in on Health Privacy

In its July 29, 2016 decision in LabMD, Inc., the Federal Trade Commission clearly signaled its intent to get more involved in the regulation of health privacy. Specifically, the case indicates that the agency intends to go well beyond its traditional role of protecting consumers against deception and to begin scrutinizing the nuts and bolts […]

mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the […]

Closer Scrutiny Ahead for DTC Genetic Testing Claims

The FDA’s public meeting on the future of clinical direct-to-consumer (DTC) genetic testing (which we have covered here, here and here) is continuing to draw significant attention from the media and other commentators. Most of the coverage, especially over the past 7-10 days, has added little that is new in the way of either reporting or analysis. One […]

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 […]

Clearing a Path for DTC Oversight

In a few hours, the FDA will kick off a two-day public meeting to consider the future of clinical direct-to-consumer (DTC) genetic tests. Few corners of the personal genomics landscape have generated as much attention from regulators, consumers and, especially, the media as DTC genetic testing. Thus, when the meeting was first announced last month, […]

HHS Pulls the Plug on Genetics Advisory Committee

The clock has run out the Secretary’s Advisory Committee on Genetics, Health, & Society (SACGHS). As reported by Turna Ray of Pharmacogenomics Reporter, the committee, which reports to Health and Human Services (HHS) Secretary Kathleen Sebelius, will have its charter extended only long enough to conduct one final meeting next month. According to Ray, SACGHS […]

The Genomics and Personalized Medicine Act Returns to Congress

Meggan Bushee is a student at the Wake Forest University School of Law. This past May, Congressman Patrick Kennedy (D-RI) and Congresswoman Anna Eshoo (D-CA) re-introduced a personalized medicine bill to the U.S. House of Representatives. The bill was originally introduced in 2006 by then-Senator from Illinois Barack Obama. While HR 5440, also known as […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]

“From Gulf Oil to Snake Oil”: Congress Takes Aim at DTC Genetic Testing

It has been a busy week in Washington for direct-to-consumer (DTC) genetic testing companies. Following public FDA meetings and a new round of FDA device notification letters earlier in the week, representatives from three major DTC genetic testing companies (23andMe, Navigenics and Pathway Genomics) were hauled in front of Congress today to defend their companies, their […]