Loophole in HIPAA Allows Fitbit to Share Health Data with Third Parties

By: Laura Stavetski   Fitbit is among the top leading companies involved in producing consumer wearables. Consumer wearables are devices that can be worn on your actual person that have the capability to monitor and record physical activity such as heart rate, number of steps taken per day, and amount of calories burned. Additionally, these… Read More Loophole in HIPAA Allows Fitbit to Share Health Data with Third Parties

Please Don’t Tag Me! Instagram for Doctors: #SpecificSymptoms, #RareDisease, #PatientConfidentiality, #PatientPrivacyRightsViolated

POSTED BY Cherie M. Ching   New informational sharing apps allow medical professionals to post photos and share comments regarding their patient’s medical conditions, similar to the components of the Instagram app.  Although these apps may provide a higher degree of efficient and effective services to medical patients, issues of breach of privacy rights and… Read More Please Don’t Tag Me! Instagram for Doctors: #SpecificSymptoms, #RareDisease, #PatientConfidentiality, #PatientPrivacyRightsViolated

Grandma Could Afford Her Arthritis Medication…If She Lived In Europe

POSTED BY Sardiaa Leney Since the passage of the Hatch-Waxman provisions 30 years ago, a fairly orderly market in generic small molecule drugs has developed, reducing the cost of some of the commonest medicines to a fraction of their pre-competition price points.  Biologics medicines are another matter.   Biologics are drugs comprising molecules so complex that… Read More Grandma Could Afford Her Arthritis Medication…If She Lived In Europe

How Much Trouble Can You Get Into For Selling Goods to the Government?

POSTED BY Sardiaa Leney Recently, whistleblowers in ‘qui tam’ actions have claimed that medical devices and drugs with defects in manufacturing or compliance with applicable regulations supplied into government-funded health care programs are actionable under the Federal False Claims Act (FCA).  A recent judgment in a long-running medical device suit in the District of Massachusetts… Read More How Much Trouble Can You Get Into For Selling Goods to the Government?

How Natural is All Natural?

POSTED BY Kayla Morency In the 1970’s, biologists began experimenting with genetics and biotechnology, which ultimately resulted in genetically engineered DNA.  This new process involved the crossbreeding of various animal, plant, viral, and bacterial genes, which would not naturally occur in the environment.  In fact, the first patented genetically modified organism (GMO) was used by… Read More How Natural is All Natural?

Healthcare Software Companies Subject to Patent Suits but Relatively Safe from Trolls

POSTED BY Rebecca M. Ferrante In light of the controversy surrounding the less than elegant release of the federal government’s healthcare website in October 2013, there is much current discussion on the topics of both healthcare and technology.  Where these topics intersect resides a host of issues concerning software durability, patient privacy, and big data. … Read More Healthcare Software Companies Subject to Patent Suits but Relatively Safe from Trolls

FDA Cordially Invites 23andMe to Bring Health Claims Up to Code

POSTED BY Lloyd Chebaclo 23andMe, the direct-to-consumer genetic testing service, is partly on hold after the U.S. Food and Drug Administration (FDA) sent it a warning letter for marketing its Saliva Collection Kit and Personal Genome Service (PGS) “without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C… Read More FDA Cordially Invites 23andMe to Bring Health Claims Up to Code