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.

We work with stakeholders throughout the life sciences and health care sectors, including pharmaceutical and medical device manufacturers, biotechnology companies, contract research organizations (CROs), site management organizations (SMOs), research site networks, clinical laboratories, research trade associations, physician groups, academic medical centers, institutional review boards, and faculty physicians to provide guidance that supports their research goals.

Our experience includes:

We assist clients in developing, maintaining, and evaluating a wide array of research compliance initiatives, including:

• Establishing, supporting, and evaluating research compliance programs.
• Establishing, supporting, and evaluating research compliance committees and research ethics committees.
• Developing policies and procedures to address privacy in research.
• Assisting in research misconduct investigations.
• Assisting in the establishment and maintenance of databanks and biorepositories.
• Preparing manuals and policies to establish and operate institutional review boards (IRBs) for health systems.
• Serving on IRBs, data safety monitoring committees, and research integrity committees.
• Developing and negotiating clinical and pre-clinical trial agreements for global pharmaceutical and medical device manufacturers, research sites, and contract research organizations.
• Developing and implementing research compliance audits and comprehensive research policies and procedures for health systems, contract research organizations, and others.
• Preparing and negotiating template clinical trial agreements for research sites, research sponsors, CROs, and SMOs.
• Developing and presenting educational modules on research topics (including “IRB Boot Camp”—a three-hour educational program on research compliance issues for IRB members and researchers).
• Analyzing and advising clients on fraud and abuse issues in the clinical research context.
• Assisting human subject protection programs in achieving accreditation.
• Assisting with due diligence related to FDA and related regulatory matters in transactions involving pharmaceutical and medical device companies.
• Advising research sites and research sponsors on privacy issues.
• Advising research sites and research sponsors on use of social media in the research context.
• Advising pharmaceutical and medical device companies on promotion prohibition.

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.

Our experience includes:

• Drafting comprehensive privacy and security policies for hospitals, health systems, physician practices, and long-term care providers.
• Drafting comprehensive privacy and security policies for global medical device manufacturers and other life sciences companies.
• Reviewing and revising privacy and security-related provisions in vendor agreements.
• Counseling clients to address privacy/security breach incidents, including compliance with HIPAA breach notification requirements.
• Providing counsel to life sciences clients on privacy issues related to social media.
• Drafting and revising privacy policies for websites and other social media platforms.

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 counsel hospitals, health systems, skilled nursing facilities, assisted living centers, physician groups and other health care providers on bioethics issues in patient care and policy development with prompt, definitive guidance.  Also, we provide pharmaceutical and medical device manufacturers with guidance relating to ethical issues triggered by cutting-edge genetics, nanotechnology, and stem cell research, and we assist with conflict-of-interest issues.  We understand the sensitive nature of ethical matters and provide clients with the guidance they need to navigate difficult circumstances.

Our experience includes:

• Establishing ethics committees and bioethics programs at numerous hospitals, health care systems, and long-term care facilities across the country.
• Serving on hospital, heath care system, and long-term care facility ethics committees.
• Developing and continuing to provide a bioethics consultation service for a large health care system, which is available 24/7 to respond to complex bioethics issues at the bedside.
• Developing policies and procedures on a wide variety of ethics issues for health care providers and life sciences companies.
• Publishing numerous peer-reviewed articles and book chapters on ethics issues confronting health care providers and life sciences companies.
• Providing pharmaceutical and medical device manufacturers with guidance on ethical issues triggered by research projects and product development plans.

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 businesses, 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 also assist in the development of contract templates and negotiation playbooks to standardize approaches and ensure consistent, compliant, business-savvy negotiation strategies.  We routinely offer in-service presentations for clients on contracting issues and provide training and day-to-day support to clients’ contract managers.

Our experience includes:

• Assisting global medical device companies in revising template equipment purchase agreements, related warranties, and service agreements.
• Revising and negotiating agreements on behalf of health systems for a variety of clinical services, including radiology, wound care, emergency room, and laboratory services.
• Developing template agreements on behalf of clinical trial sponsors and sites, including site management agreements, contract research organization agreements, and clinical trial recruitment services agreements.
• Drafting and negotiating co-marketing agreements on behalf of global pharmaceutical manufacturers.
• Drafting and negotiating consulting agreements for health systems and life sciences companies.
• Assisting with due diligence review of health care compliance matters in connection with prospective mergers and acquisitions.
• Developing policies for reporting business relationships and payments under Sunshine/transparency regulations. 

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.

Our experience includes:

• Developing health system policies on a variety of health information and medical records issues, including using scribes in hospital and clinic settings.
• Developing a comprehensive, updated privacy and security policies for health systems, in response to amended HIPAA regulations and operational challenges.
• Providing day-to-day guidance on treatment decision-making for patients, discharges against medical advice, and reporting abuse.
• Developing comprehensive and streamlined informed consent policies for health systems, along with supporting consent form templates and training.
• Assisting health care providers’ approaches to use of interpreters, in alignment with Americans with Disabilities Act and federal non-discrimination regulatory requirements.
• Reviewing and revising medical staff bylaws and rules and regulations to comply with applicable laws and standards and to modernize approaches to medical staff structure and functions.
• Developing policies and template language for health care providers’ peer review activities to ensure they receive privilege and immunity protections. 

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.

Our experience includes:

• Reviewing and revising medical staff bylaws and rules and regulations, and templates for physician employment contracts, to assure a coordinated and consistent approach to medical staff leadership and physician employees.
• Assisting hospitals, academic medical centers, and affiliated universities with policies and procedures that facilitate compliant and efficient information exchange.
• Counseling hospitals and health care systems with respect to corrective actions and assist with fair hearings.
• Serving as mediator in disputes involving medical staff membership and clinical privileges.
• Assisting clients in obtaining guardianship and protective placement for patients, including routine guardianships of person and estate, contested guardianships, emergency guardianships, and involuntary administration of psychotropic medication orders. 

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.

Our experience includes:

• Developing corporate compliance programs for global medical device companies.
• Serving as Compliance Officer for a life sciences client.
• Preparing and revising policies and procedures related to specific compliance risk areas, consistent with clients’ unique needs and resources.
• Developing corporate compliance programs for academic medical centers.
• Designing and conducting compliance training sessions for clients at management and workforce levels.
• Assisting with internal investigations and remediation.
• Conducting due diligence reviews of compliance programs in correlation with prospective mergers and acquisitions.
• Presentations and training for boards of directors on compliance oversight obligations.

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.

Our experience includes:

• Counseling long-term care clients regarding regulatory compliance issues.
• Assisting long-term care clients with administrative hearings relating to regulatory/compliance issues.
• Assisting long-term care clients to develop policies and procedures relating to privacy, resident rights, and resident care issues.
• Assisting long-term care clients in development and functioning of bioethics committees.
• Assisting long-term care clients with drafting, reviewing, and negotiating contracts with consultants and vendors.
• Reviewing and revising resident admission and services agreements to assure compliance with applicable law and business needs.
• Assisting clients in obtaining guardianship and protective placement for patients, including routine guardianships of person and estate, contested guardianships, emergency guardianships, and involuntary administration of psychotropic medication orders.