Ropes & Gray offers the resources of a multidisciplinary team that can advise you on the most critical areas related to operating in the digital health market. Our practice strengths in such a broad range of key areas enable us to help digital companies at each stage of their experience:
- Collecting and using data
- Conducting platform security assessments
- Managing anti-kickback issues, Medicare reimbursement and other sales-related considerations
- Assessing and mitigating risk, and ensuring compliance
- Financing growth and expansion
- Licensing and collaboration
- Meeting corporate governance requirements and expectations
- Addressing litigation and enforcement issues
Wide-Ranging Practice Strengths
Ropes & Gray provides unsurpassed perspective on the regulatory, privacy, business and financial considerations facing any company with digital health operations or aspirations.
In areas such as health care, privacy and data security, and technology, we have unsurpassed perspective on the regulatory, privacy, business and financial considerations facing any company with digital health operations or aspirations.
Privacy & Data Security
Our leading privacy & data security practice regularly advises clients on HIPAA and other privacy laws governing the use and handling of sensitive personal and health information. Additionally, our data breach response team advises clients on internal investigations and helps them establish and test audit and incident responses before a breach occurs.
We are well positioned to help you comply with the rapidly evolving laws, regulations and oversight govern- ing the U.S. and global digital health market. Our FDA regulatory team has extensive experience in all relevant areas, including FDA classification of software as a medical device, device clearance and approval, FDA Quality System Regulation, adverse event reporting, and device labeling. In addition, our FTC regulatory team has extensive experience counseling companies on FTC data privacy issues and handling FTC investigations.
We have also worked closely with both vendors and users to design, develop, license, implement and operate health IT systems that securely and effectively integrate patient health information into a centralized network.
Establishing an intellectual property strategy and obtaining valid patent protection can be challenging for digital health companies. As a result, digital health companies typically rely on a combination of patent, copyright, trade secret and contract rights to protect their businesses. Our attorneys have vast experience helping clients develop and implement a practical protection strategy for the various intellectual property rights on which their businesses depend. Additionally, our IP litigators have a record of courtroom success in a variety of patent infringement, trademark and false advertising cases.
Licensing and Collaboration
Remaining competitive in the digital health market often requires collaboration, which presents challenges relating to the rapidly changing technological landscape. We are deeply experienced in all aspects of licensing and collaborations relevant to digital health vendors and users, including co-promotion, marketing and distribution agreements, strategic alliances, outsourcing, supply and manufacturing agreements, and joint ventures.
The mix of health care, life sciences and technology companies involved makes investing in the digital health market particularly complex. Our longstanding leadership in M&A and private equity, wide-ranging transactional experience, and long track record in capital markets and private financings give us a thorough understanding of the issues facing digital health investors and companies alike.
Regulators and third parties are increasingly focused on making sure that digital health enterpris- es have the proper corporate governance safeguards to protect the integrity of the business and its data. We routinely advise companies on critical compliance and governance issues, including the development of structures that promote regular, accountable over- sight and proper employee training.
Our digital health group has broad experience advising digital health companies and the financial institutions that invest in the space, including:
- Privacy & Data Security
- Regulatory/Health Care
- Intellectual Property
- Licensing and Collaboration
- Corporate Governance
Privacy & Data Security
- Advised Partners Healthcare System, Inc. in connection with a variety of complex data security issues, including compliance with HIPAA and other state and federal regulations. Our advice to Partners has included privacy and data security matters involving use and transmission of data worldwide.
- Conducted analysis of the telemedicine laws of several Northeastern states with respect to a client hospital’s proposal to offer second opinions to patients over the Internet. In undertaking this analysis, we focused on the corporate practice of medicine, HIPAA privacy notice obligations, and application of the Medicare/Medicaid anti-kickback statute to the client’s proposed fee arrangements for the second-opinion service.
- Represented a nationally-recognized Boston-area hospital in connection with an investigation by the OCR relating to the loss of an external hard drive containing protected health information (the “Incident”). OCR’s investigation was focused on the academic medical center’s compliance with the HIPAA Privacy and Security Rules and Breach Notification Rule.
- Represented a leading multinational pharmaceutical company in response to a breach of security of one of its doctor portal systems that contained personal patient information. Our team advised in regards to its incident response and breach notification obligations.
- Advised several companies on the applicability of FDA regulation requirements to mobile medical device applications, message boards, and other social media platforms.
- Advised a major international software technology company in connection with regulatory compliance issues, including those under federal privacy and security rules, relating to the development and operation of health information exchange platforms and infrastructure.
- Advised leading vendors of hospital information software on the FDA regulatory status of the system.
- Advise North Shore-Long Island Jewish Health System (NSLIJ) on an ongoing basis as it continues to ensure that its hospital and physician groups meet the requirements of the Medicare and Medicaid EHR Meaningful Use Incentive Programs.
- Advised Orion Health in reviewing its internal policies and procedures which support its Health Information Exchange services, in reviewing and negotiating contracts with its Health Information Exchange clients as well as its subcontractor vendors, and with addressing privacy and security requirements and challenges.
- Served as health care regulatory counsel to Stryker Corporation in connection with its acquisition of a physician-led, health care services company that provides service-line consulting and data analysis services to hospitals and other health care providers.
- Represented Epic Systems in a patent infringement case involving hospital digital health interfaces for controlling systems of IV medication delivery.
- Represented Allscripts Healthcare Solutions in a patent infringement suit relating to electronic health records and accessing and collecting prescriptions.
- Represented digital health companies in a wide variety of intellectual property matters, including patent prosecution, opposition and reexamination proceedings, portfolio development and strategy, and due diligence. We provide strategic advice, in both the U.S. and Europe, for product development and for protecting clients’ patents.
Licensing and Collaboration
- Advised Express Scripts, the nation’s largest pharmaceutical benefits manager, in connection with its core 3rd party IT service provider relationships.
- Represented a leading global biotechnology company in a strategic collaboration with a leading global technology and data analysis company focused on further elucidating the progression of a specific disease of interest.
- Represented Partners Healthcare System, Inc. (“Partners”) in the negotiation of its software license for its system-wide, comprehensive EHR technology. This contract was one of the biggest in HIT history. The negotiation entailed interfacing with an interdisciplinary team to ensure that all aspects of the client’s needs were met in terms of technology scope, licensing terms, regulatory compliance, and business needs.
- Represented Welsh, Carson, Anderson & Stowe in its acquisition of GetWellNetwork, Inc., a healthcare technology company providing interactive patient care and engagement solutions to hospitals and healthcare organizations.
- Represented Cressey & Co. in its sale of Strategic Healthcare Programs, a web-based healthcare technology company.
- Represented a leading global investment advisor in connection with its investments into cutting edge technology companies, including the premier cloud based file and data backup company, and companies presenting leading solutions in wearable technology and digital personal health systems.
- Advising a major medical device manufacturer on its international data governance policies, it’s launching of an international informatics business, and the data handling, security and compliance issues related to its products and services.
- Advising a leading global pharmaceutical company in the development of a digital media governance program.