Join Seton Hall Law & Helen Oscislawski & Other Esteemed Speakers on September 17th for Panel Discussions on Balancing Privacy and Public Health in a COVID-19 World

Join Seton Hall Law & Helen Oscislawski & Other Esteemed Speakers on September 17th for Panel Discussions on Balancing Privacy and Public Health in a COVID-19 World

Seton Hall Law’s Institute for Privacy Protection and Gibbons Institute of Law, Science & Technology is hosting a Virtual Event on September 17th with legal academics, practitioners, and government officials who will evaluate the impact of the COVID-19 pandemic on privacy and intellectual property. Panel One speakers will discuss balancing privacy & public health; Panel Two will discuss Intellectual Property – incentives to access to vaccines & treatments.

read more
Looks Like the FTC Is Ramping up for Enforcement of Health Apps

Looks Like the FTC Is Ramping up for Enforcement of Health Apps

This past Tuesday the FTC hosted its 5th annual PrivacyCon. It was a GREAT event!  The full-day event covered a wide-range of cutting edge and titillating issues concerning the privacy of data in this day and age of rapidly accelerating technology.  However, it was the morning session which covered Health Apps that interested me the most. In his opening remarks, the Director of FTC’s Bureau of Consumer Protection, Andrew Smith, came out-of-the-gate pointing out that earlier this year HHS issued rules that will make it easier for consumers to access their medical records through the app of their choice, and while this expanded access to health information can be an enormous benefit to consumers – wherever data flow opportunities increase, the opportunities for data compromise increase as well. Director Smith concluded his opening remarks by stating “We at the FTC will not hesitate to take action when companies misrepresent what they are doing with consumers’ health information or otherwise put health data at undue risk . . .” Here is what I learned from the four-person panel of experts who discussed the ins-and-outs of Health Apps and potential direction of the FTC will take with enforcement.

read more
Is Your Organization Ready to Send Patient Information to Apps by November?

Is Your Organization Ready to Send Patient Information to Apps by November?

Becker’s Hospital Review reported that 70% of CIOs are “concerned” about meeting the upcoming November 2nd deadline for complying with the Final Rules prohibiting information blocking practices. This is according to a survey conducted by CHIME, which included responses from executives at academic medical centers, critical access hospitals, multi-hospital systems and specialty hospitals.  Although the survey did not appear to identify specifically what concerns CIOs about complying with information blocking rules by this fall, one possibility is fully understanding how ONC’s information blocking rules will apply to releasing patients’ EHI to third-party apps.

read more
Changes on the Horizon for Part 2 Confidentiality Regulations

Changes on the Horizon for Part 2 Confidentiality Regulations

As part of its comprehensive COVID-19 response, Congress quietly passed through changes to the federal drug and alcohol confidentiality framework known as “Part 2” under the CARES Act, enacted on March 27.   One of the more underreported components of the CARES Act, the changes do not completely overhaul the Part 2 regulations, however, they relax several restrictions that health care providers have struggled with, particularly in the electronic exchange and electronic health records (“EHR”) context (the “CARES Act Changes”).

read more
Will ONC’s Final Rule put HIEs between a “Block and a Hard Place”?

Will ONC’s Final Rule put HIEs between a “Block and a Hard Place”?

Under the ONC’s Final Rule on Information Blocking, Health Care Providers, HIEs and HINs will be legally prohibited from interfering with the access, exchange, or use of EHI unless an exception applies. However, HIEs/HINs that are HIPAA Business Associates are not allowed to use or further disclose PHI other than as permitted or required by their HIPAA BAAs with respective health care providers. So, what happens if a Health Care Provider and its HIPAA Business Associate HIE/HIN disagree on whether an exception allows EHI to be withheld from access, exchange or use under a certain set of specific facts?

read more

ACO Rule Keeps HIE Consent “On the Fence”

When DHHS published its Proposed ACO Rule in April 2011 and then the Final ACO Rule in November 2011 (I’ll refer to them as the “ACO Rules”), discussions focused predominately on issues such as who is “qualified” to participate, what the required governance structure should be, what methodology will be used to assign Medicare beneficiaries, and what the payment models will be.  However, as I digested the ACO Rules, my reading deliberately slowed down as I zeroed in on the not unremarkable language and comments CMS included with regard to sharing individually identifiable health information in the ACO context.

read more

Archives