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Ryan Blaney represents health care, life science, and technology clients in a range of regulatory, enforcement, internal investigative and transactional matters, with particular expertise in privacy law, life sciences and digital health. He also has expertise in regulatory compliance, counseling clients on a range of matters, including health care fraud and abuse, third party reimbursement, data breach issues, data privacy and security, and FDA regulatory matters. He has substantial experience in pharmaceutical lifecycle management and competition issues, including the Hatch- Waxman Act and Biosimilars Price Competition and Innovations Act.

Ryan serves information technology companies, public and private health care companies, hospitals and physician organizations, manufacturers, medical device companies, and health plans. He guides venture capital groups, private equity funds, investment banks, and other investors on health care regulatory issues in connection with financing, mergers and acquisitions, and restructuring.

Ryan’s work is greatly informed by his experience as a teacher. Prior to attending law school, Ryan earned a master’s degree in education and taught at an under-resourced Catholic middle school. He is known for his ability to communicate clearly and to coordinate large teams working on complex matters. Outside of his health law practice, Ryan has been repeatedly recognized for his public service and pro bono work. He has successfully handled numerous education-related cases, helped establish three nonprofit organizations and defended qualified recipients of disability benefits.

This is the second of two posts discussing the June 11, 2021 updates to the PRF reporting requirements and FAQs.

As discussed in our earlier blog post, on June 11, 2021, the U.S. Department of Health and Human Services (“HHS”) released revised COVID-19 Provider Relief Fund (“PRF”) Reporting Requirements, superseding all prior versions of reporting requirements issued by HHS, along with associated revised PRF FAQs, Reporting Portal FAQs, and a Reporting Portal Registration User Guide that each make conforming changes. In addition to the new deadlines discussed in the prior post, the June 11 PRF updates offer providers more clarity into the the priority of eligible uses, required reporting elements, and instructions on how to return unused funds.Continue Reading HHS Offers Increased Flexibility Regarding the Use of Provider Relief Fund Grant Money and Associated Data Reporting Obligations

This is the first of two posts discussing the June 11, 2021 updates to the PRF reporting requirements and FAQs.

On June 11, 2021, the U.S. Department of Health and Human Services (“HHS”) released revised COVID-19 Provider Relief Fund (“PRF”) Reporting Requirements, superseding all prior versions of reporting requirements issued by HHS, along with associated revised PRF FAQs, Reporting Portal FAQs, and a Reporting Portal Registration User Guide that each make conforming changes. The updated Reporting Requirements come just three weeks prior to when PRF recipients would have been required to expend all received funds and when reporting was scheduled to commence (July 1, 2021).

Significantly, the updates give providers a longer runway to use funds, clarify the definition of “COVID-19 patient”, and provide insight into potential upcoming PRF distributions. The updated Reporting Requirements represent the Biden Administration’s first actions to modify the PRF, which distributes federal grants to help providers offset revenue shortfalls and expenses incurred due to the COVID-19 pandemic.Continue Reading In Significant Update to the Provider Relief Fund, HHS Sets New Deadlines for Providers to Spend PRF Grant Money and Report Uses

As is the case with most new technologies or significant industry innovations, companies embracing and driving the disruptions often move very fast in a legal and political landscape that is always playing catch-up. This is very true for the fast-growing telemedicine and digital health industries. However, likely motivated by COVID-19, state governments are moving faster than they traditionally do to pass new regulations and to extend certain regulatory waivers.

COVID-19 required a shift in the delivery of medical care with the state and local lockdowns. During the pandemic, the United States Department of Health and Human Services (HHS) has issued guidance on various compliance waivers and enhanced flexibility. Governors across the country issued executive orders to help address the requirements of providing ongoing medical care while maintaining proper social distancing (e.g., New Mexico, Texas, etc.). The result was more people receiving medical care remotely. Similar to the realization by many that working from home was not only feasible but in some cases preferable, many also came to the conclusion that a trip to the doctors’ office was not necessary for the treatment of certain conditions.
Continue Reading Propelled by COVID-19, State Governments Attempt to Keep Up With Telemedicine Innovation and Digital Health Platforms

Although vaccine rollout began slowly in the United States, millions of people are now being vaccinated against COVID-19 per day. As individuals receive the vaccine, states have been collecting personal health data in individual immunization registries. Experts say this data collection is essential to effectively monitor vaccination progress, report adverse reactions, compare vaccine efficacy in cross sections of the population, and keep track of who needs second doses and when.
Continue Reading Federal Vaccination Tracking Raises Privacy Concerns