Health Law

Health Information Technology & Electronic Health Records

Information technology is at the center of the ongoing reform of the US health care industry. Groundbreaking innovations in how patient information is stored, analyzed, shared, and used are occurring at a rapid pace. Opportunities abound for your success in the market.

But with these opportunities come complex legal and business challenges. Developing, marketing, and implementing health IT can be especially complicated if you are a vendor or end user. For starters, technology licensing and other business arrangements must comply with state and federal privacy and security rules, health care fraud and abuse laws, and, for wireless devices, FCC and FDA requirements.

The Health Information Technology for Economic and Clinical Health (HITECH) Act contains financial incentives for hospitals and physicians participating in the Medicare or Medicaid programs who engage in “meaningful use” of electronic health records (EHRs). Our Health Law attorneys can provide your company timely, effective advice on the qualifications for receiving funding for EHR adoption and navigating the application process.     

The complexity of health care regulations is not abating any time soon as various federal agencies are in the midst of regulatory reform that could directly or indirectly affect health IT, how your company complies with industry regulations, and how these agencies interact. Our Health Law attorneys and our government relations affiliate, ML Strategies, LLC, continually monitor relevant legislative and administrative developments and maintain important relationships with decision makers in Congress and at key government agencies. Our clients do not miss a beat, and they stay ahead of policy developments.

A hallmark of our firm is its deep pool of knowledge and experience across many practice areas, which comes into play regarding health IT transactions. Our Health Law attorneys regularly collaborate with the firm’s Intellectual Property, Communications, and Corporate & Securities lawyers to advise clients 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.

Also, health information technology is the primary driver for businesses that seek to deliver health care in innovative ways, such as through traditional telemedicine and increasingly in an online setting through web-based technologies. Antiquated state laws and rules developed to address the delivery of care in an office pose major challenges to the deployment of telehealth services even though the provider and patient communities have embraced telehealth. The sources of these legal impediments may be statutes, medical board or pharmacy board regulations, individual disciplinary administrative cases or informal guidance, and will differ from state to state. Varying state requirements for an “adequate physical exam” and the issuance of a prescription in an online setting continue to pose business challenges. Our Health Law attorneys can help you address the impact of these varying standards on your business and operational decisions. And, working with ML Strategies, LLC, we can help you formulate an effective strategy for working with state medical and pharmacy boards in order to deploy a compliant, multistate telehealth service.

Representative Experience

  • Provided strategic and legal advice to the Massachusetts Health Information Technology Council, which was charged with developing a statewide Health Information Exchange.
  • Represented hospital systems in strategic collaborations with major IT companies.
  • Assisted integrated health care providers seeking to revamp and integrate their IT systems for revenue cycle management, billing, and patient administration.
  • Negotiated 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.
  • Acted as general counsel to an international software company providing clinical information and EHR systems for critical, peri-operative, and acute care environments.
  • Advised the independent state agency (known as the Connector) formed to manage Massachusetts’s health insurance program on the substantial outsourcing of its customer service center operations.
  • Served as general counsel to a software company providing an automated platform for case, disease, and population management.
  • Advised a multispecialty physician group on procuring an EHR system.
  • Advised a community hospital on procuring a web-based patient communication portal.
  • Negotiated a strategic distribution arrangement with a leading telecommunications carrier for an international mobile health IT applications company.
  • Negotiated a strategic exclusive license arrangement with a large EHR vendor and health care data analytics company for distribution of an integrated platform.
  • Negotiated SaaS agreements for a health care data analytics company offering subscription-based data analytics products.
  • Advised a pharmacy benefits manager on procurement of a new claims processing platform.
  • Advised an online behavioral health company on online contracting, licensing, and distribution matters.
  • Drafted and negotiated IT vendor agreements necessary to help a late-stage biotech company prepare for commercial operations in anticipation of the launch of its first drug, including cloud services agreements, a master agreement to build and implement an IVRS / IWRS system to support clinical trials, a master agreement to implement and provide an enterprise-wide expense report system, a sales force automation service for the company’s commercial drug team, a data management / storage services agreement, and a master services agreement to implement and provide a data management solution to support various departments.
  • Negotiated an outsourcing agreement with an Indian data processing company for a health care data analytics company.
  • Washington Post Online Medical Clinic Virtuwell Now Available in Virginia Ellen L. Janos is quoted discussing state policies on the standard of care for telemedicine.
  • Medical Practice Compliance Alert OIG, CMS Extend, Change Subsidy Protections for EHR Adoption Karen S. Lovitch is quoted discussing the decision to extend the protections allowing physicians to accept a subsidy of up to 85% of the cost of EHR software without violating the Stark law and anti-kickback statute.
  • FierceEMR CMS,OIG Extend EHR Safe Harbor Through 2021 Karen S. Lovitch is quoted discussing the regulations released by CMS and OIG which extend the sunset date for donation of items and services for electronic health record adaptation to 2021.
  • BNA’s Medicare Report HHS Extends Protections for EHR Donations Through the End of 2021 Karen S. Lovitch is quoted discussing the extension of legal protections for donations of electronic health record products and other health information technologies through 2021.
  • Health IT Security Preparing HIPAA BAs, Subcontractors for 2014 OCR Audits Dianne J. Bourque quoted discussing what covered entities and  business associates should expect if they are audited by the Office for Civil Rights.
  • Jerusalem Post mHealth in the Era of Obamacare Susan W. Berson is quoted discussing healthcare IT under the Affordable Care Act.
  • Healthcare Risk Management OMG! How Many of Our Hard Drives Are Out There? Dianne J. Bourque is quoted discussing the potential HIPAA violations associated with photocopier hard drives.
  • Healthcare Risk Management Photocopiers Seen as HIPAA Risk After $1.2 Million Payout Dianne J. Bourque discusses Affinity Health Plans settlement for breaching HIPAAA regulations.
  • Health IT Security One Month Until HIPAA Omnibus Compliance: Current Trends Dianne J. Bourque is quoted discussing the upcoming deadline which requires all healthcare organizations to be compliant with the HIPAA omnibus rule.
  • American Medical News EHR Transition Causes Its Own Headaches Dianne J. Bourque is quoted discussing the importance of negotiating agreeable terms with electronic health record system vendors.
  • HealthITSecurity HIPAA Omnibus Rules Already Influencing Covered Entities Dianne J. Bourque discusses how the new rules have already begun impacting covered entities and BAs alike since they took effect in January.
  • Reuters Groups React to New Rules for Electronic Health Karen S. Lovitch explains that even though federal agencies continue to allow electronic health record technology donations to be made, some state authorities consider such donations illegal under state laws.
  • Health IT Security Will HIPAA Omnibus Subcontractor Rules Reduce Data Breaches? Dianne J. Bourque is quoted discussing the implications of the new HIPAA Omnibus rule.
  • Final HIPAA Final Rule Stricter than Interim Regulation on Data Protection Dianne J. Bourque is quoted discussing the recently released  final HIPAA Omnibus rule.
  • BNA’s Daily Health Care Report Health Information Outlook 2013: Interoperability Tops Health IT Issues for New Year Thomas S. Crane discusses the top health information technology issues for 2013.
  • American Medical News Stage 2 Meaningful Use Success Rests on 3 Elements Dianne J. Bourque is quoted discussing the importance of patient engagement and data security as physicians work to meet stage 2 requirements.
  • PhysBizTech Concerns Raised about Stage 2 Measures beyond Physicians’ Control Dianne J. Bourque is quoted discussing the Stage 2 meaningful use final rule.
  • Search HealthIT Impact of Stage 2 Meaningful Use Rules to be Big, But Surprises are Few Dianne J. Bourque is quoted discussing the finalized Stage 2 meaningful use rules. Ms. Bourque explains that the rule that extends the deadline for meeting the requirements of Stage 2 will be beneficial to the health care industry.