Across the country, hospitals, physician groups, health plans, pharmacies and pharmaceutical companies, technology companies and interested investors and advisors are increasingly pursuing opportunities in the health care system’s information technology revolution. Attorneys in Sonnenschein’s Health Care Information Technology (HCIT) practice provide our clients with the full range of legal assistance that a HCIT arrangement, venture or project might require.
Transactional and Corporate Matters
Members of Sonnenschein’s HCIT group have handled a wide variety of HCIT-related deals. These range from spin-offs and sales of companies to acquisitions, financings and ventures in health care transaction processing. Sonnenschein has provided advice on insurance claims processing outsourcing services, and counseled an international pharmaceuticals client in connection with structuring and negotiation of communications services arrangements. We have represented hospitals, health insurers, regional health information organizations, hardware, software and service vendors, telecommunications organizations, and data clearinghouses in the sale and acquisition of HCIT. By combining our transactional experience, our technology expertise and our regulatory sophistication, we have helped clients, large and small, realize their business objectives.
Information Security and Internet Enforcement
The clinical and economic value of health care data is well recognized. Every organization that uses or creates patient data must be concerned with maintaining that data’s security and reliability. Unique to Sonnenschein’s HCIT resources is our technical and legal expertise in the area of data security. In addition to counseling on legal compliance with HIPAA and other federal and state information security regulations, our attorneys and Internet investigators conduct data security audits, as well as develop policies and practices pertaining to incident handling, terms of service, and electronic monitoring. This group, which is led by former computer crime prosecutors from the U.S. Department of Justice, includes attorneys with CISSP certifications who have extensive experience in the management of information security issues. Unusual for a law firm, Sonnenschein also employs a team of non-lawyer information security professionals who operate our in-house computer forensics lab. Consequently, Sonnenschein is uniquely qualified to advise clients on information security best practices, and to investigate security incidents and track down those causing harm within or outside a company in the event of a security breach.
Regulatory Compliance
The HCIT Group draws upon some of the country’s most experienced and sophisticated regulatory attorneys. We have counseled hospitals, insurers, data clearinghouses, regional health information organizations and physicians groups on the full range of privacy, data security, transaction and code set requirements. We have worked with health care privacy laws in every state in the U.S. and across the globe.
Of course, regulatory compliance goes well beyond privacy and data security. Among the more complex regulatory areas that require careful attention by HCIT organizations is the application of health care fraud and abuse laws to HCIT arrangements. Whether in terms of dissemination of HCIT by hospitals to physicians or the terms of business deals between technology companies and their customers, applicable fraud and abuse laws must be carefully examined. HCIT arrangements may also raise other regulatory issues. For example, in some instances, medical software may be subject to the regulation of the Food and Drug Administration. In other instances, clinical research regulations may apply, and any electronic medical record must conform to state law medical recordkeeping obligations. In all these scenarios, Sonnenschein’s HCIT group can help organizations achieve compliance and, if needed, provide defensive counsel.
Emerging Companies
Members of Sonnenschein’s Venture Capital and Technology group have counseled HCIT and other entrepreneurs through the many legal and business challenges that may confront an emerging, innovative technology firm. Sonnenschein lawyers are familiar with corporate, tax, intellectual property, securities, employment and other issues that, when well addressed, better position a growing company to raise capital, hire and retain talent and focus on achievement of its business plan.
Intellectual Property
Sonnenschein lawyers have handled the full range of Intellectual Property protection activities in the HCIT space. These include patent prosecutions, the negotiation and drafting of hardware and software licensing agreements, copyright protection activities and the use of IP strategies to protect patient databases.
Public Finance
A major challenge for community wide and regional health information organizations is the development of adequate sources of capital. Private players face different but similarly challenging funding needs. Sonnenschein’s HCIT group includes public finance and financial transactions and securities lawyers skilled in developing creative strategies for the raising of capital.
Litigation and Dispute Resolution
Disputes will inevitably arise in the use, acquisition or development of HCIT and health care data, and Sonnenschein litigators bring a wealth of relevant advocacy skills to that context. Beyond having served as counsel to one of the nation’s largest clinical research organizations in a dispute with a major data clearinghouse over the rights to data conferred by a data transfer agreement, we regularly handle the type of commercial, intellectual property and technical subject matter likely to be involved in an HCIT controversy.
Public Policy Strategies
Increasingly, federal and state governments recognize the power of information technology to improve medical care, reduce medical errors, make health care administration more efficient and give more power to patients. Congress and state legislatures are becoming more active, both to create incentives for more rapid dissemination of HCIT and to protect the public from unintended or wrongful consequences of the HCIT use. Attorneys in Sonnenschein’s HCIT group have been called on by the Department of Health and Human Services, the Office of the National Healthcare Information Technology Coordinator, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality and the Veterans Health Administration to offer advice on various HCIT public policies and proposed laws and regulations. Members of Congress and the General Accountability Office have also asked for our counsel. As representatives of leading HCIT trade associations, standard-setting bodies, physicians organizations, hospital groups and HCIT companies, we regularly participate in the formation of public policy.
Antitrust Considerations
As competitors seek to make HCIT interoperable, concerns regarding the implications for anti-competitive activities must be considered. Regional health information organizations, standard-setting bodies, and other efforts to allow HCIT to share data seamlessly may come under the scrutiny of antitrust regulators. Sonnenschein’s HCIT group includes antitrust attorneys equipped to counsel companies seeking to collaborate in the development of interoperable standards for HCIT.
back to top
