Our speakers will provide up-to-the-minute legal, regulatory, and policy developments in the health care and life sciences sector, with an eye towards future risks and opportunities. Note that this program is geared toward companies with significant U.S. operations.
NEW THIS YEAR – Health Care Essentials for In-House Counsel
Prior to kicking off our traditional conference programming, we will be offering a day of Health Care Essentials sessions, valuable programming geared towards new in-house counsel, offering them first-hand knowledge and insight into key areas of health care law. These sessions are also an excellent refresher for experienced health lawyers and health professionals building their practice.
For questions, please contact Lindsay Korenich.
Health Care Conference sessions include:
Making the Value-Based Rules work for the digital age | Wednesday, December 8, 2021 | 10:00 AM EST |
During this program, our panelists will explore the application of the final Anti-Kickback Statute and Stark Law value-based rules to arrangements involving digital health and device technology.
Legal considerations for early-stage financing in life sciences and health care | Wednesday, December 8 | 12:00 PM ET |
This program will provide practical guidance on the main terms and considerations for early-stage venture capital investments. We will discuss how to tailor diligence to the size and stage of the target, prioritizing those issues that may have a long term impact on value. We also will consider the various options and processes for stock financing.
Latest developments in compounded medication | Wednesday, December 8, 2021 | 2:00 PM ET|
There have been a lot of changes in the compounding industry over the past year. Compounded medication touches on a many different aspects of health care, including pharmacy practice, physician practice, hospital operations, and telehealth, among other things. This presentation will cover recent trends in the compounding space and the implications of these trends on the health care industry.
The national COVID-19 vaccine mandates are here: What should health care industry employers do to comply? | Thursday, December 9, 2021 | 10:00 AM ET |
This webinar will discuss what employers in the health care industry – particularly those participating or enrolled in the Medicare and Medicaid programs – need to know about the recently released CMS Rule and OSHA Emergency Temporary Standard, and legal challenges to such requirements. Our health care and labor & employment teams will address frequently asked questions on these rules, scope of coverage under both rules – including interaction with the OSHA Emergency Temporary Standard issued in June and applicable to certain health care workspaces – and provide timely and important information regarding what employers in the health care industry can and should be doing now to comply with the specifics around vaccination, testing, exemptions, and continued participation in Medicare and Medicaid.
Why data security is the biggest concern in healthcare and strategies to protect against ransomware attacks | Thursday, December 9, 2021 | 12:00 PM ET|
Ransomware attacks have risen in the United States by over 150% in the wake of economic challenges presented by the COVID-19 pandemic. Ransomware attacks and other cyber incidents are a growing problem in the health care space, putting patients, providers and organizations at risk. This session will discuss the liabilities and risks associated with medical record exposure due to ransomware, data breaches and other cyber incidents. It will also cover how to insure against ransomware events, best practices for maximizing insurance recovery, HIPAA considerations and strategies to protect against future attacks.
Health Care Essentials sessions include:
Health Care Essentials: HIPAA - fundamentals & operationalizing compliance | Tuesday, December 7, 2021 | 9:00 AM ET |
This session will introduce you to the HIPAA regulatory frame work (who is and is not regulated), and provide practical considerations to ensure your HIPAA compliance program meets the Office for Civil Rights’ tick list.
Health Care Essentials: Introduction to FDA’s regulation of software as medical devices | Tuesday, December 7, 2021 | 11:00 AM ET |
This session will cover the FDA’s general framework for devices, including what the FDA regulates, how medical devices are classified, and important industry terms and definitions. Our presenters will then delve into recent policy changes that impact the regulation of software as a medical device, and what companies should consider when they are designing software to be used in a health care context. The presenters will cover certain categories of SaMD and will discuss when these products require premarket review. This session would be particularly relevant for in-house counsel at companies operating in this space, or those contemplating products or acquisitions involving software as a medical device.
Health Care Essentials: You received a Civil Investigative Demand: Now what? Tips for conducting health care and life sciences government investigations | Tuesday, December 7, 2021 | 1:00 PM ET |
This session will provide practical tips for responding to government civil investigative demands and subpoenas, including considerations for conducting investigations remotely.
Health Care Essentials: The life cycle of a health care transaction | Tuesday, December 7, 2021 | 3:00 PM ET |
This session will take attendees through the anatomy of a health care transaction, all the way from marketing the deal to post-closing filing and integration referencing real-life examples across the spectrum of health care deals handled by our team. Our presenters will provide detailed insight into the legal considerations in play during all of the major steps in a deal, including how to structure the deal, what to include in the purchase agreement, conducting proper due diligence, and the documentation needed for pre- and post-closing.
CLE: Each webinar is presumptively approved for 1.0 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.
