Health & Life Sciences

Long before discussions of electronic medical records and sharing of health information became commonplace, pharmacies, PBMs and drug wholesalers were building collaborative databases and networks that gathered and stored patient prescription and evidence-based pharmaceutical data. Once gathered, the data was consulted and shared by and among key participants in the drug delivery system to assure the prompt delivery of appropriate care and payment. Standing on common ground with our clients and our colleagues, we have a proud history of advancing the delivery of health care through technology and uncommon vision.

Quarles & Brady’s team of attorneys advises clients on a wide range of regulatory and business aspects of health care technology. We have worked extensively on clinical trials, privacy issues, product development agreements and health records matters. As technology and sharing of data across organizations has become increasingly complex, we have made it our business to understand the business of providing medical care, both from the provider and vendor sides, and we are nationally recognized for our experience in health technology and electronic medical records issues.

Quarles can assist clients in the following health care technology matters:

• Health care information privacy and confidentiality – Quarles advises its clients on their privacy and confidentiality obligations, which is primarily regulated federally under HIPAA. The recent amendments to those rules in the recent federal stimulus legislation — the Health Information Technology for Economic and Clinical Health Act (“HITECH”) of the American Recovery and Reinvestment Act of 2009 (“ARRA”) — constitute the most sweeping changes to HIPAA since its enactment in 2003. These amendments, among other things, rendered business associates directly subject to HIPAA regulation. The result is that vendors of all kinds, including those that provide technology and related services to health care providers, as of June 2010, may be subject to onerous regulatory obligations. Our team understands these changes and has worked with clients to ensure compliance with the new rules.
  
  
• Interface of federal law with state law – We have experience in 50 states and regularly advise clients regarding the sometimes-conflicting federal and state rules on privacy, electronic medical records and other health technology matters.
  
  
• Funding the implementation of health technology – Our attorneys have in-depth knowledge of the federal and state incentives available for implementing EMR systems and other health technology projects, as well as the financial penalties that could result if conversions are not done properly. In addition, we assist health care providers in obtaining and structuring financing to purchase and maintain EMR and other data-sharing systems. With our supplier clients, we assist in crafting and negotiating sales and distribution agreements.
  
  
• Health information exchange – As health care entities look for ways to share electronic health information across systems and providers, we work with our clients to establish legal entities that allow them to share medical records in a way that is compliant with federal requirements without violating state laws (including privacy laws). We closely follow the regulatory and legislative changes and advise clients on how to navigate this quickly developing area.
  
  
• Telemedicine – Telemedicine is becoming increasingly important as health care providers look for ways to improve patient care and stretch limited resources by exchanging health information from one site to another for consultative, diagnostic and treatment services. We assist clients in developing information-sharing agreements, software licenses and other agreements related to telemedicine initiatives.
  
  
• Software and other licensing agreements – We assist our clients in the negotiation and drafting of licensing agreements with vendors. We also assist innovative companies in entering into development agreements for the tracking of medical equipment used to research clinical outcomes through the use of software and web-based applications to enhance and provide for more innovative pharmaceutical and biotechnology products.
  
  
• Clinical trials – Quarles assists our pharmaceutical, medical device, biologic and biotechnology clients on questions involving clinical trial strategies and compliance (including Good Clinical Practices, Institutional Review Boards and patient informed consent); Good Manufacturing Practice and Quality Systems Requirements (including assisting in third party audits and drafting SOPs); Clinical Laboratory Improvement Act compliance; and drafting and negotiating clinical trial, laboratory services, manufacturing and supply agreements, as well as handling other issues that arise during a product’s progression from pre-market clinical testing to post-market commercial distribution.
  
  
• Data privacy and security - We assist clients in developing policies to help guard electronic health information and with remediation if a data breach occurs.

For more information on how our Health Care IT Team can assist you, please contact your local Quarles & Brady attorney.