Health Information Technology 

Mintz Levin brings its communications, corporate, health law, and intellectual property capabilities to bear when advising clients on the many legal and business challenges presented by the ground-breaking level of innovation in, and adoption of, health IT. Through the use of information technology, the health care system is becoming more efficient and effective, and new software and systems are leading to innovative ways to store, analyze, share, and use patient information. As always, new opportunities raise new questions, and Mintz Levin attorneys have the background and experience necessary to help clients address them.

Now is the time to focus on health IT. The Obama administration has set an ambitious goal of full adoption of electronic health records (EHRs) by 2014, and the Health Information Technology for Economic and Clinical Health (HITECH) Act has established financial incentives for hospitals and physicians participating in the Medicare or Medicaid programs who engage in “meaningful use” of EHRs. In addition, the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), Federal Communications Commission (FCC), and other government agencies have indicated plans to reform regulations within their respective jurisdictions that could directly or indirectly affect health IT, potentially changing how new technologies come to market, how companies comply with industry regulations, and how these agencies interact. To ensure that our clients do not miss a beat, Mintz Levin and ML Strategies, our government relations affiliate, continually monitor relevant legislative and administrative developments and maintain relationships with decision makers in Congress and at key government agencies.

Developing, marketing, and implementing health IT can be especially complex.Technology licensing and other business arrangements must comply with state and federal privacy and security rules, health care fraud and abuse authorities, and, for wireless devices, FCC and FDA requirements. Mintz Levin brings together attorneys across various disciplines to advise clients effectively on all facets of health IT transactions. 

Continue reading below to learn more about our experience in:

Getting Products to Market
HITECH Funding and Meaningful Use
Stark and Anti-Kickback Compliance
Privacy and Security/Data Breach Counseling
Emerging Technologies

Because we work with both vendors and end-users, Mintz Levin has the ability to view every transaction from multiple perspectives and to successfully guide clients through the range of issues that emerge. For example, we counsel software and technology companies that are developing and marketing health IT, yet we also work extensively with health care providers and third party payors seeking to integrate legacy systems and to implement new capabilities. 

Highlights of Mintz Levin’s Health IT experience include:

• Providing strategic and legal advice to the Massachusetts Health Information Technology Council, which is charged with development of a statewide Health Information Exchange 
• Representing hospital systems in strategic collaborations with major IT companies
• Assisting integrated health care providers seeking to revamp and integrate their IT systems for revenue cycle management, billing, and patient administration
• Negotiating strategic collaborations with consumer health portals, e-prescribing vendors, payment processing service providers, and consumer health content publishers for an innovative provider of online care
• Acting as general counsel to an international software company providing clinical information and EHR systems for critical, peri-operative, and acute care environments 
• Advising the independent state agency formed to manage Massachusetts’ health insurance program on the large-scale outsourcing of its customer service center operations 
• Serving as general counsel to a software company providing an automated platform for case, disease, and population management 
• Advising a multi-specialty physician group on the procurement of an EHR system

Getting Products to Market

Our health law attorneys collaborate with the firm’s intellectual property and corporate lawyers to advise clients — both end-users and vendors — on commercial licensing transactions, distribution arrangements, and strategic collaborations.  We regularly structure and negotiate domestic and international agreements governing joint technology development, licensing and distribution, hardware and systems acquisition, outsourcing, and other complex transactions. Our work is informed by our expertise in health law and by our substantive knowledge of the technologies involved, including the Internet, data and e-commerce, computer hardware and software, telecommunications, networking and remote access systems, implantables, sensors, and PDAs, among others. Because we understand the issues facing both parties to these transactions, we can effectively advise clients on business issues such as pricing and ongoing liability, and on the identification and inclusion of effective contract provisions.

HITECH Funding and Meaningful Use

The HITECH Act provides $36 billion to promote the implementation of health IT, especially the adoption and meaningful use of EHRs. To ensure that clients receive timely, effective advice on the qualifications for receiving federal incentives for EHR adoption, we constantly monitor regulatory developments in this area.  Further, we already are advising clients on the funding that will be available, the qualifications for obtaining it, and the application process.     

Stark and Anti-Kickback Compliance

Because health IT transactions can create financial and business relationships among health care providers, payors, and vendors, the parties must consider how to avoid running afoul of state and federal health care fraud and abuse laws. For example, the donation of an EHR system or e-prescribing technology by a hospital or laboratory to a physician group raises questions under the Anti-Kickback Statute and the Stark Law and similar state laws. Our health law attorneys are well-versed in the requirements of the safe harbor to the Anti-Kickback Statute and the exception to the Stark Law governing donations of EHR systems and e-prescribing technologies and can advise clients on how to structure EHR donation arrangements to avoid health care compliance pitfalls. 

Privacy and Security/Data Breach Counseling

With the recent spotlight on the adoption and use of EHR systems and other aspects of health IT, end-users and vendors now more than ever must focus on the privacy and security of patient health information. Mintz Levin attorneys have in-depth knowledge of the HIPAA Privacy and Security Rules, and we are tracking and analyzing the new business associate requirements and other standards enacted as part of the HITECH Act. We also advise clients on state-mandated privacy protections, data breach, and consumer protection laws, as well as privacy and personal data protections under EU and international law. Our work also includes conducting information privacy and security audits, assisting clients on the development and implementation of comprehensive privacy and security compliance programs, advising on compliance with subpoenas and third party requests for information, and counseling clients on the investigation, mitigation, and resolution of data breaches. 

Emerging Technologies

Health IT intersects with communications law and regulations.  Some emerging health care technologies — such as wireless devices used to track and transmit clinical data — are regulated by the FCC as well as the FDA. While the FDA governs the approval, manufacturing, and promotion of such devices, the FCC makes spectrum available for their operations and regulates the cellular and other wireless carrier networks over which they operate. In addition, the American Recovery and Reinvestment Act provides for additional funding to develop broadband infrastructure to support telemedicine programs and rural health initiatives. We combine our communications law practice with our health law and FDA experience to advise clients on the cutting-edge issues facing companies in the emerging technology space.