- Posts by Elizabeth ScarolaMember of the Firm
Clients across the health care industry rely on attorney Elizabeth Scarola to help them navigate the complexity of today’s regulatory environment. Elizabeth brings an insider’s perspective to her health care practice.
Recently, Florida Governor Ron DeSantis signed Senate Bill 262 and Senate Bill 264 into law. These new laws grant Floridians greater control over their personal data and establish a new standard for data handling and protection. Senate Bills 262 and 264 take effect on July 1, 2023.
As employers continue their efforts to safely bring employees back to the workplace, many have moved beyond initial pre-entry wellness checks or questionnaires and are considering technology solutions that monitor social distancing and conduct contact tracing in real-time. Along with introducing these enhanced capabilities, the question of the privacy and security of employee personally identifiable information (“PII”) and protected health information (“PHI”) continues to loom.
In order to isolate and contain the spread of COVID-19, one critical component of an ...
While providers struggle to provide health care to their patients amid the coronavirus contagion concerns, recent regulatory and reimbursement changes will help ease the path to the provision of healthcare via telehealth.
On March 6, 2020, President Donald Trump signed into law an $8.3 billion emergency coronavirus disease 2019 (“COVID-19”) response funding package. In addition to providing funding for the development of treatments and public health funding for prevention, preparedness, and response, the bill authorizes the U.S. Secretary of Health and Human Services, Alex Azar (referred to herein as the “Secretary”), to waive Medicare restrictions on the provision of services via telehealth during this public health emergency.
Greater utilization of telehealth during the COVID-19 outbreak will reduce providers’ and patients’ exposure to the virus in health care facilities. Telehealth is especially useful for mild cases of illness that can be managed at the patient’s home, thereby decreasing the volume of individuals seeking care in facilities. To further facilitate the increased utilization of telehealth, the Centers for Disease Control’s interim guidance for healthcare facilities notes that healthcare providers can communicate with patients by telephone if formal telehealth systems are not available. This allows providers to have greater flexibility when telehealth technology providers lack the bandwidth to accommodate this increase in telehealth utilization or are otherwise unavailable.
Earlier this month, the FDA released programmatic guidance intended to clarify the current review practices for the Humanitarian Device Exemption (“HDE”) Program (“Guidance”) reflecting recent changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures. The Guidance addresses frequently asked questions about FDA actions on HDE applications, post-approval requirements, and includes a filing checklist to clarify the required information for the FDA to consider whether an HDE application is ready for substantive review.
Florida has been at the forefront of some very interesting healthcare M&A activity in the past year, including an influx of private equity and consistent growth in Hospital and Health Plan vertical integration. Unless subject to antitrust filing requirements, these high profile transactions are typically carried out under veils of confidentiality and announced upon completion. However, Florida M&A is not insulated from recent Florida House health reform initiatives. If the Florida House gets its way, the pace of healthcare transactions in Florida may hit a speed bump in the form ...
One well-recognized way to protect patient privacy is to de-identify health data. However, trends around increases in publicly-available personal data, data linking and aggregation, big data analytics, and computing power are challenging traditional de-identification models. While traditional de-identification techniques may mitigate privacy risk, the possibility remains that such data may be coupled with other information to reveal the identity of the individual.
Last month, a JAMA article demonstrated that an artificial intelligence algorithm could re-identify ...
- DOJ’s FY 2023 Statistics: Highest Number of Settlements, Judgments, and Civil Investigative Demands in History and a Continued Health Care Focus
- FDA Releases Updated Directory on Select Dietary Supplement Ingredients
- In Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute
- NJ Approves Cannabis Regulatory Amendment with Major Impacts on Class 5 Retail License Holders
- Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities