We recognize that quality health care begins with quality clinical research, and that thoughtful attention to the ethics of clinical research is essential for researchers, research institutions, research sponsors, patients, and policy makers.
With heightened public scrutiny and ongoing government enforcement, conducting and sponsoring research has become subject to an increasingly complex maze of regulations. We have experience and insight to help clients maintain compliance in an ever-changing regulatory environment.
In our Privacy & Data Security practice, we help clients assure privacy protection and strengthen data security; and if a data breach or cybersecurity incident occurs, we help them address it. For health care providers and life sciences clients, we assist with development of privacy and security policies and procedures, perform due diligence and risk assessments, and guide clients through incidents of data breach. We work with clients in and outside the U.S. to provide global privacy counsel in the health care and life sciences sectors.
Privacy & Data Security
Ethical and legal issues at the bedside in clinical research, and in business development of life sciences clients can be gut-wrenching and complicated. Informed consent, decision-making capacity, advance directives, surrogate decision-making, confidentiality, organ donation and transplantation, genetic testing and the fair allocation of resources are examples of issues that arise in health care delivery. We have nationally recognized expertise and extensive experience in these issues.
We offer counsel to our health care and life sciences clients in diverse business transactions. We help academic medical centers, community hospitals, and physician groups to draft, review, and negotiate a variety of contracts relating to their business transactions, ranging from confidentiality agreements and vendor service agreements to more complicated agreements such as consortium agreements, consulting agreements, and master services agreements. We take a practical and efficient approach, working with clients to meet their business goals as well as their budgets.
We work with clients to address health care regulatory compliance issues by providing day-to-day guidance, developing and updating policies and procedures, preparing responses to regulatory agencies, conducting focused compliance audits, assisting with investigations, and providing training and education to assure that practices comply with the ever-changing health care regulatory landscape. Issues we address include privacy, HIPAA compliance, treatment decision-making, medical staff matters, peer review and quality improvement, scope-of-practice, licensure and certification, Medicare Conditions of Participation, Joint Commission standards, and fraud and abuse and anti-bribery.
Health Care Regulatory Compliance
We understand the important and complex issues that arise from inter-relationships of staff status, physician employment, and faculty membership. We help hospital and academic medical center clients navigate these issues to assure consistency, synergy, and regulatory compliance in approaches to credentialing, information exchange, and accountability.
Hospitals and Academic Medical Centers
Our health care and life sciences clients know that corporate compliance programs are essential for identifying risk; minimizing liability exposure; and assuring adherence to high ethical, business and legal standards. The importance of corporate compliance programs has intensified in recent years with government’s expanded focus on prosecuting fraud and abuse. We have extensive experience in assisting health care and life sciences clients to develop, implement and maintain effective corporate compliance programs.
Corporate Compliance Programs
We provide counsel to long-term care clients, including nursing homes, assisted living providers, hospices, and independent senior living facilities. We assist our long-term care clients with a variety of issues, including state and federal regulatory compliance, privacy, fraud and abuse counseling, bioethics and resident care matters, and business agreements.