Transformed by digitization and invention, the health industry has evolved to become one of the largest and most critical sectors of the economy. In this rapidly-changing sector, the use of technology presents vast opportunities, paired with significant risk.
Michael Best’s Digital Health team understands the heightened compliance burden and legal risk faced by healthcare entities. We help clients effectively navigate a complex regulatory environment and capitalize on the many opportunities available to entities in the digital health market.
Our cross-practice team provides a complete range of legal services and has deep knowledge of the unique issues affecting companies in the digital health space:
- Corporate and transactional
- Intellectual property protection and litigation
- Licensing and technology agreements
- Privacy and data security
- Regulatory compliance
We serve a variety of healthcare clients, including hospitals, healthcare providers and networks, electronic medical records providers, health insurers, universities and academic health centers, pharmaceutical and biotech companies, medical device manufacturers, laboratories and diagnostic companies, healthcare tech companies, healthcare data aggregators, and joint ventures.
Corporate & Transactional
The convergence of health care, life sciences, and technology has made the digital health market particularly complex to navigate for investors. Our Corporate & Transactional group provides strategic legal counsel covering the entire business life cycle — from organization, financing, and operation through mergers, acquisitions, and divestitures. Our lawyers provide guidance on matters such as contract negotiations, corporate formation and governance, deal structuring, tax planning, dispute resolution, and more.
Digital health companies need intellectual property counsel that will enhance and safeguard their competitive position. Michael Best attorneys have deep experience helping clients develop, manage, protect, and enforce their brands and technologies worldwide. Our IP Group is prepared to provide the full range of legal services related to intellectual property, including in patent, trademark, trade secret, and copyright law; portfolio management; enforcement; clearance; defense; and litigation.
Licensing & Technology Agreements
As technology has become central to daily life, technology and intellectual property have also become increasingly central to business agreements. Michael Best helps digital health clients capitalize on crucial technology and IP assets through licensing, joint development, and other strategic alliances. Our Licensing & Technology Agreements team offers a special blend of legal, business, and technical knowledge. By bringing together attorneys from our Intellectual Property and Corporate groups who consult with other practice areas as needed, we provide unified counsel on all facets of IP licensing and technology transactions.
Privacy & Data Security
In today’s data-driven, digital world, privacy and data protection are increasingly important and absolutely crucial in heavily regulated sectors such as healthcare. We help healthcare clients act as good custodians of sensitive information, meeting stringent regulatory requirements while also using data to its full potential. We provide a variety of legal advice and representation in privacy and data security matters involving:
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and Security Rule
- Health Information Technology for Economic and Clinical Health (HITECH) Act Privacy Act
- Genetic Information Nondiscrimination Act (GINA)
- Patient Protection and Affordable Care Act (ACA)
- FTC Health Breach Notification Rule
- Employment-related privacy regulations
- Online and telephone marketing regulations
- State laws on privacy and data protection
Navigating the complexities of the ever-changing health sector regulatory environment can be a daunting task. Michael Best advises clients on compliance matters and helps them stay current with the evolving laws and regulations governing the digital health sector. Our FDA Regulatory team covers the full spectrum of regulation by the U.S. Food and Drug Administration (FDA) and other product regulation agencies. We provide regulatory counsel on a broad range of products, such as wireless medical devices, mobile medical apps, Health IT, telemedicine, and software as a medical device (SaMD), among others.
We assist clients throughout the entire product life cycle, starting with premarket services, such as:
- Product classification and developing regulatory strategies
- Preparing and prosecuting full premarket submissions for various product types, including medical devices, electronic products, and medical software
- Reviewing design control and product validation programs
- Registration, listing, and prior notice for imports
We also assist clients with issues involving multiple regulatory agencies, such as the interplay between FDA and the FTC in the regulation of advertising and data privacy issues.
Michael Best Strategies LLC
Michael Best Strategies LLC (Strategies) is the firm’s dedicated business consulting, government relations, and public affairs affiliate. Strategies helps clients achieve their business goals by developing—and deploying—carefully considered strategic business plans in conjunction with a full range of services, including lobbying and public relations.