Month: November 2017

FDA Approves First Digital Pill

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The U.S. Food and Drug Administration has approved the country’s first drug with a digital ingestion tracking system.

Abilify MyCite is a pill that digitally tracks whether patients have taken the medication.  The pill contains a sensor that, once ingested, sends a message to a patient’s wearable patch, which then transmits the information to a smartphone application.  This voluntary process allows patients, caregivers, and physicians to track this information through a web-based portal if the patient has given consent.  Experts believe that such digital devices could have a positive impact on public health by addressing a longstanding problem; in this case, that patients do not take their medicines as prescribed.

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A Bipartisan Effort to Focus on Healthcare Cybersecurity

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House Energy and Commerce Committee members Reps. Billy Long (R-Mo.) and Doris Matsui (D-Calif.) introduced the HHS Cybersecurity Modernization Act earlier this month in a bipartisan effort to address cybersecurity threats to the Department of Health and Human Services (HHS).  Representatives Long and Matsui have both described the bill, H.R. 4191, as a stepping-stone towards improving cybersecurity at HHS and the health care industry at large. However, the bill does not authorize any additional appropriations to do so.

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A.G. Schneiderman Announces SHIELD Act to Protect New Yorkers

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The Stop Hacks and Improve Electronic Data Security Act (SHIELD Act) was introduced in the New York legislature in early November and would amend New York’s state breach notification law.  The bill was announced after the release of a New York Office of the Attorney General report found a nearly 60% hike in data breaches affecting state residents in 2016 and following the Equifax breach in September, which A.G. Schneiderman is investigating.

Among other things, the SHIELD Act would:

  • Require reasonable security for private information, using standards tailored to the size of the business, while avoiding duplicate regulations and providing incentive to businesses that certify security compliance and provides clear examples of safeguards (e.g., technical, administrative, and physical measures).
  • Carve out “compliant regulated entities,” which are defined as those already regulated by, and compliant with, existing or future regulations of any federal or NYS government entity (including NYS DFS cybersecurity regulations; regulations under Gramm-Leach-Bliley; HIPAA regulations) by deeming them compliant with this law’s reasonable security requirement.
  • Provide safe harbor from AG enforcement actions under this law for “certified compliant entities,” (those with independent certification of compliance with aforementioned government data security regulations, or with ISO/NIST standards).
  • Provide a more flexible standard for small business (less than 50 employees and under $3 million in gross revenue; or less than $5 million in assets): requiring reasonable safeguards “appropriate to the [small business’s] size and complexity.

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The Sedona Principles, Third Edition Gives a Shout Out to Information Governance

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The Sedona Conference®, a nonprofit research and educational think tank dedicated to the advanced study of law, has released a final, pre-publication version of its much-anticipated The Sedona Principles, Third Edition: Best Practices, Recommendations and Principles for Addressing Electronic Document Production. The Sedona Principles are the preeminent reference publication for e-discovery lawyers and practitioners alike.  In addition to addressing the 2015 changes to the Federal Rules of Civil Procedure, this latest version of The Sedona Principles includes a fresh focus on information governance and the mitigating effect it can have on the challenges organizations face today from the ever-changing electronic data landscape.

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Latest OCR Reminder Regarding Mobile Device Security and PHI

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With the ever-increasing use of mobile devices in the workplace that create, receive, maintain, and transmit electronic protected health information (ePHI), the Department of Health and Human Services (HHS), Office for Civil Rights (OCR)’s latest Cybersecurity Newsletter issued an important reminder of the importance of mitigating the risks surrounding the use of mobile devices.

Mobile devices pose unique security risks because of their portability, small physical size, and capacity to store vast amounts of data. Both the Federal Trade Commission (FTC) and OCR frequently remind all organizations, but especially those entities that process ePHI, of the importance of protecting data on mobile devices.

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“Hey toy – can you …”

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The Federal Trade Commission provided additional guidance on how the Children’s Online Privacy Protection (COPPA) Rule, 16 C.F.R. Part 312, applies to the practice of collecting audio files that contain a child’s voice, immediately converting the audio to text, and deleting the files containing the voice recording triggers COPPA’s requirements.

The FTC guidance provides that it will not take enforcement action against operators who collect audio files without first obtaining verifiable parental consent in situations where the child’s voice is being used solely as a replacement for written words, such as to convert voice to text in order to perform a search and other function on internet-connected devices.

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