Digital Health

Digital Health

Increasing consumer demand, the development of pioneering technologies, and a move to value-based care have generated a disruptive digital healthcare sector as the industry rapidly progresses the digital health ecosystem in response. As the doctor-patient relationship evolves beyond the in-person encounter, digitized data and technology have converged with healthcare delivery and payment. This fast-changing digital health market presents both enormous opportunities and equally significant risks. As a result, digital health and telemedicine companies will face a complex set of business, legal, regulatory, privacy, and policy issues evolving in real time. 

Kendall PC understands the digital health environment, its nuances, and its complexities. Our digital health team works with clients to create solutions that improve access to medical services and products and engage patients in managing their healthcare, all while navigating the complex and dynamic legal and regulatory considerations.

Contact Kendall PC today online or at (484) 414-4093. We serve digital health companies of all sizes and stages of development throughout the United States and across the globe.

Kendall PC works as a multi-disciplinary team for our digital health clients through the collaboration of our healthcare compliance; pharmaceutical, medical device, and biotechnology; regulatory; data protection and privacy; litigation; and business startup and corporate governance teams of attorneys. We offer guidance on all aspects of digital health, including product liability matters; regulatory and compliance challenges; data protection and privacy; commercial transactions; investigations; and the formation and governance of business entities, joint ventures arrangements, mergers and acquisitions, and strategic alliance partnerships. Our attorneys advise clients across the digital health landscape, including companies focusing on:

  • Telehealth and telemedicine
  • Mobile health (mHealth) 
  • Health information technology
  • Big data and data strategies

Litigation

Our cross-practice litigation team handles a wide variety of litigation (and threatened litigation) matters, including: 

  • Medical malpractice and professional liability 
  • Healthcare litigation
  • Settlement discussions
  • Anti-Kickback Statute litigation 
  • Healthcare Fraud Statute litigation
  • Corporate Practice of Medicine litigation and other corporate liability matters
  • US False Claims Act litigation
  • Physician Self-Referral (Stark) Law litigation
  • Consumer class action and other consumer-related litigation
  • Development, production, sale, and distribution disputes

Healthcare and Clinical Compliance 

The skilled healthcare and clinical compliance attorneys at Kendall PC have the knowledge and experience to help clients with the legal issues surrounding the digital health sectors. We understand the intersection between technology, delivery of services, regulatory matters, patient privacy, and legal issues that accompany digital health. Additionally, telemedicine is governed by a patchwork of state and federal laws and regulations that are constantly evolving to incorporate novel technologies and industry best practices. We provide guidance to clients on navigating the varied state-based regulations and regulatory definitions associated with telehealth and telemedicine. 

Within these areas, our work typically encompasses: 

  • Policy development and implementation 
  • Compliance training
  • Risk assessments, audits, and gap analysis 
  • Day-to-day “help desk” compliance support
  • Industry benchmarking 
  • Due diligence and monitoring processes
  • Coverage and payment matters 
  • Healthcare professional licensure, credentialing, and privileging
  • Fraud and abuse matters including Anti-Kickback Statute, False Claims Act, Physician Self-Referral (Stark) Law issues 

Regulatory Counsel 

Our seasoned team of regulatory attorneys is well-positioned to help telehealth and telemedicine, mHealth, health information technology, and big data companies comply with the rapidly evolving laws, regulations, and oversight governing the U.S. and global digital health market. Kendall PC’s team of digital health attorneys helps clients navigate through the myriad of regulatory issues posed by digital health technologies, products, and services. We have extensive experience in all relevant areas including regulatory classification of software, devices, and combination products; pre-market clearance and approval; issues pertaining to digital health products associated with pharmaceuticals or developed in collaboration with drug manufacturers; U.S. Federal Drug Administration (FDA) Quality System Regulation (QSR); adverse event reporting; regulation of healthcare and e-commerce services; pricing and reimbursement; and market access rules. In addition, our team of regulatory attorneys works in collaboration with our data protection and privacy team on counseling digital health companies on Federal Trade Commission (FTC) data privacy issues. 

We regularly advise clients on regulatory and compliance matters, including: 

  • FDA, Federal Trade Commission (FTC) and U.S. Consumer Product Safety Commission jurisdiction matters 
  • FTC data privacy matters 
  • Clinical study requirements 
  • Pre-submission meetings and pre-market approval submissions 
  • Complaint handling 
  • Adverse event and recall reporting
  • Quality System Regulation (QSR) compliance 
  • Inspection and enforcement issues
  • Labeling and promotional compliance 

Government Investigations

Kendall PC handles investigations involving a range of law enforcement agencies, including the U.S. attorney’s offices, DOJ, and state attorneys general. We have extensive experience in defending digital health companies in government investigations into alleged violations under the Federal Food, Drug and Cosmetic Act, the Anti-Kickback Statute, and state and federal False Claims Acts, among others. We handle complex multiagency government investigations, including managing parallel investigations by federal and state government entities and settlement and corporate integrity agreement (CIA) discussions and negotiations. 

Our government investigations team of attorneys counsel clients on the following government investigation matters: 

  • Suspensions and debarments
  • Anti-Kickback Statute 
  • Physician Self-Referral (Stark) Law 
  • Corporate Practice of Medicine 
  • FDA Form 483 and Warning Letter Responses
  • Foreign Corrupt Practices Act, UK Bribery Act, and other fraud and corruption matters investigations 
  • False Claims Act investigations
  • Deferred prosecution agreements 
  • US federal and state government civil investigative demands and administrative subpoenas
  • Corporate Integrity Agreement (CIA) negotiations
  • Billing and coding practices
  • Price reporting practices, including discounting and rebate practices 
  • Medicare, Medicaid, and other US healthcare program matters 

Commercial Contracting 

Kendall PC’s commercial contracting practice combines legal knowledge with deep sector experience to cover the full spectrum of commercial and business law issues companies must address on a daily basis, with a myriad of relationships and contracts that bind them to their suppliers, customers, licensors, distributors, and other strategic partners. These complexities are intensified by the regulatory obligations that impact every facet of operations within the digital health sector. We also understand that remaining competitive in the digital health market often requires collaboration. Our team of attorneys has decades of experience advising companies on all aspects of licensing and collaborations relevant to digital health companies in the telemedicine and telehealth; mHealth; health information technology and big data client sectors, including: 

  • Co-promotion
  • Marketing and distribution 
  • Technology transfer and licensing 
  • Collaborations 
  • Outsourcing and managed services
  • Supply and manufacturing 
  • Commercial transactions 
  • Vendor relationships, bidding processes, and procurement 

Data Protection and Privacy

Our team of data protection and privacy attorneys regularly advises clients on Health Insurance Portability and Accountability (HIPAA), FTC, and other privacy and security laws governing the collection, processing, use, and handling of sensitive personal and health information. We have extensive experience with data protection and privacy matters pertinent to digital health companies including: 

  • Developing and implementing fit-for-purpose HIPAA compliance programs, including HIPAA policies and procedures 
  • Audits of HIPAA compliance and training workforce members
  • Use and disclosure of protected health information under US federal and state healthcare privacy laws 
  • Drafting and negotiating business associate agreements 
  • Data breach response and litigation 

Business Startup, Formation and Corporate Governance

Kendall PC understands that market entry into the digital health sector is complicated by the patchwork of regulatory requirements and state laws. Our Business Startup, Formation, and Corporate Governance attorneys work closely with our clients to understand the relevant state and federal framework that applies to their unique circumstances, evaluate potential business risk, and make informed business and operational decisions. We have extensive experience in counseling digital health companies on creating the appropriate corporate structure, ensuring that professional licensure requirements are met as necessary, creating businesses models that incorporate applicable requisite standards of care, and evaluating and addressing potential compliance issues. Our team also provides counsel to clients in the digital health and telemedicine sector on mergers, acquisitions, joint ventures, and strategic alliance proposed transactions.    

Contact Kendall PC Today

To learn more about how our team of seasoned attorneys can help your digital health company, contact Kendall PC today online or at (484) 414-4093. We serve companies of all sizes and stages of development throughout the United States and across the globe.

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