Members of Alston & Bird’s HIT Task Force and their colleagues have provided bipartisan legislative and policy, regulatory, IT transaction, transactional, litigation /government investigations and security incident management expertise to our clients on a wide range of health, technology and health information privacy matters for years. We have harnessed this experience into a HIT Task Force specifically designed to help clients:
- develop and implement legislative, administrative and policy strategies, including the passage of laws and the issuance of regulatory rules and policies, that would maximize their benefit from business opportunities being created within the HIT space;
- advocate policy solutions (by members of the Task Force who are registered lobbyists) with members of Congress and administration officials, as well as their respective staffs;
- build and manage industry coalitions and conduct grassroots and grasstops outreach;
- monitor and analyze legislative, regulatory and other policy developments through our HIT List, which provides real-time updates on current events relating to HIT;
- identify policy trends and issues that may impact their businesses;
- draft amendments to bills for congressional markup, comments on proposed federal agency regulations, letters to members of Congress and administration officials, and analyses and talking points for advocacy efforts;
- negotiate health care information technology transactions for both health care providers and vendors covering a diverse range of solutions for both clinical and financial operations, including client-server software, hosted and web-based applications and information exchanges;
- handle litigation and government investigations;
- comply with regulatory requirements under HIPAA, the HITECH Act and PPACA; and
- navigate the various state and federal laws and reporting and notification requirements that arise when the privacy or security of health and financial information is breached.
Alston & Bird routinely assists its clients at all stages of the health care life cycle in the sale, licensing and acquisition of HIT. Our attorneys negotiate sophisticated IT acquisition agreements and agreements to outsource our clients’ technology needs. They also have significant experience in establishing technology licensing programs for licensors or sellers of technology. Our attorneys work with clients in the integration of their technology or technology-based services into the technology offerings of their partners (or vice versa). They frequently advise clients and negotiate on their behalf consulting agreements for the development of such technology as online services and customized software. Our clients include vendors of health information—software vendors, hardware manufacturers and system integrators, private and public health care providers, and service providers who outsource functions that transform, manipulate or process health care information.
Alston & Bird has one of the nation’s largest groups of corporate finance and mergers and acquisitions attorneys dedicated to the health care industry, and the firm is regarded as one of the country’s best in this practice area. Our corporate health care lawyers work side by side with members of our firm’s regulatory compliance, government investigations, technology, life sciences and other practices to assemble top-notch teams to accomplish our clients’ objectives. Whatever the transaction—public or private, financing, merger, acquisition, joint venture or corporate reorganization—our team has done it repeatedly and successfully.
Health Care Regulatory
Alston & Bird’s health care regulatory attorneys have extensive experience in regulatory matters affecting the health care industry on a national and regional basis, including fraud and abuse, the Anti-Kickback Statute, the Stark Law, HIPAA, Medicare and Medicaid reimbursement, False Claims Act litigation and billing investigations, and more. Our regulatory attorneys regularly deal with the agencies that oversee health care, including the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA) and the HHS Office of the Inspector General (OIG).
In particular, our attorneys are familiar with the HITECH Act, the incentive structure for healthcare providers who adopt and make “meaningful use” of certified EHRs, and the standards and other requirements for certified EHR technologies. Our clients include the full range of relevant businesses, from start-up vendors, service providers and small physician practices to Fortune 100 companies that offer health information technology, healthcare analytics and comprehensive healthcare delivery systems.
Alston & Bird is at the forefront of national law firms in advising clients on health information privacy, security and breach notification issues under HIPAA and the HITECH Act, as well as under the laws of the various states, and in developing compliance plans for health care providers, health plans and health insurance companies, health care clearinghouses, and their business associates. Alston & Bird also has expertise in advising clients on the electronic transactions standards and operating rules under HIPAA and PPACA for administrative and financial transactions among participants in the health care industry.
Legislative and Public Policy
Alston & Bird’s HIT Task Force includes members of the firm’s health care public policy practice, which is one of the most experienced, full-service regulatory and legislative public policy teams in the United States. It is distinguished by its range of talent, depth of experience and degree of success. The HIT Task Force has harnessed this experience to develop and implement legislative, administrative and policy strategies; advocate policy solutions; build and manage industry coalitions; conduct grassroots and grasstops outreach; and more. This range in policy and legal talent enables us to handle diverse and complex issues in a way that is second to none. We can tackle issues using a variety of means and have realized great success through this depth in resources.
Litigation and Government Investigations
Alston & Bird has decades of experience supporting national and international clients on health information technology and privacy litigation, including significant data breach investigations. Our government and investigations lawyers regularly advise HIT companies, hospitals, physicians, payers, and other HIPAA-covered entities on how to protect the health information privacy of patients and customers, including in response to subpoenas, requests for production, search warrants and motions to compel. In doing so, we utilize our expertise in HIPAA and the various state laws that protect certain diagnoses (e.g., HIV, AIDS, mental health, alcohol/drug treatment, developmental disabilities), as well as laws that protect certain communications (e.g., privileges for psychiatrists, psychologists, social workers and therapists).
A major advantage Alston & Bird offers HIT clients is our ability to work effectively with federal, state and local regulators. Our attorneys and policy counselors are recognized leaders and bring a unique and practical results-oriented perspective to client issues. Our health care attorneys and policy counselors include:
- A former member of Congress;
- A former deputy general counsel and acting general counsel of HHS;
- Two former health policy advisors and counsel to the Senate Finance Committee;
- A former associate chief counsel for Medical Devices and for Enforcement at the U.S. Food and Drug Administration;
- One of “America's Leading Lawyers” for information technology matters, who is also the current secretary and former chair of the Technology Section of the State Bar of Georgia;
- A former U.S. attorney and a number of former assistant U.S. attorneys;
- A former deputy assistant to the president and health policy advisor to a senator;
- A former chief of staff to a member of Congress;
- A co-chair of Alston & Bird’s Privacy and Security Group, an attorney who is listed in Chambers USA: America’s Leading Lawyers for Business;
- The head of Alston & Bird’s IP Technology Transactions Group, an attorney who is admitted to practice before the U.S. Patent and Trademark Office.