Long before discussions of electronic medical records and sharing of health information became commonplace, hospitals, clinics, pharmacies, medical suppliers, pharmaceutical manufacturers and distributors, health care payors, and all of their business partners were contemplating and building ways to share data. Hospitals and physician groups worked on interoperable shared records to optimize patient care. Pharmacies and their partners worked on collaborative databases and networks to gather and store patient prescription and evidence-based pharmaceutical data. The health care industry has worked for decades to use and share data in the most efficient way possible, to ensure the prompt delivery of appropriate care and payment. As the laws and standards governing health information technology have changed at startling pace, Quarles has adapted and stood on the cutting edge. For decades, standing on common ground with our clients and our colleagues, we have been advancing the delivery of health care through uncommon vision and the compliant use of technology.
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, from both 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 health care clients on a daily basis regarding the use, disclosure, receipt and maintenance of patient health care records and the protection of protected health information therein. Quarles has a deep bench of attorneys who specialize in the privacy and security of health information. Our attorneys regularly advise clients and speak at conferences nationwide on issues relating to HIPAA and its intersection with other laws (such as those regulating alcohol and substance abuse programs, more stringent state confidentiality and data breach laws, and many others.) Because all of these laws change at a rapid pace, Quarles proactively keeps clients apprised and ready to handle upcoming changes in hospital requirements for managing health information. Quarles has developed numerous templates and resources to assist hospitals with ongoing compliance including a "toolkit" for privacy and security, as well as separate toolkits for business associates (now regulated directly by HIPAA).
- 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 to 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.