Erin M. Bosman

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“My Google Home Mini was inadvertently spying on me 24/7 due to a hardware flaw,” wrote a tech blogger who purchased Google Inc.’s latest internet of things (IoT) device. Following the incident, a pact of consumer advocacy groups insisted the U.S. Consumer Product Safety Commission (CPSC) recall the Google smart speaker due to privacy concerns arising when the device recorded all audio without voice command prompts. The CPSC is charged with protecting consumers from products…
Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the Health Insurance Portability and Accountability Act (HIPAA) that—among other things—broadened the definition of a “Business Associate,” many technology companies found themselves wondering whether they were, or were not, subject to HIPAA. Health and Human Services (HHS) recently issued some guidance, Health App Use Scenarios & HIPAA,…
Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the Health Insurance Portability and Accountability Act (HIPAA) that—among other things—broadened the definition of a “Business Associate,” many technology companies found themselves wondering whether they were, or were not, subject to HIPAA. Health and Human Services (HHS) recently issued some guidance, Health App Use Scenarios & HIPAA,…
Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance documents, which were originally promised by the FDA in 2010, represent the FDA’s latest attempt to provide direction for drug and device manufacturers concerning how and when they may use social media. BACKGROUND Drug and device labeling and promotion are highly regulated activities, subject to…
In late May 2013, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a “device” under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA). The mobile app—the uChek Urine Analyzer developed by Biosense Technologies Private Limited and available through the iTunes App store—allows a user to…