Health technology is a dynamic growth sector of the healthcare industry beset by strong regulatory challenges. Our exceptional knowledge of this industry outpaces the competition. We advise health technology companies on business and regulatory matters, including Medicare, U.S. Food and Drug Administration (FDA), and HIPAA compliance. Our attorneys have successfully helped health technology businesses structure new business ventures, resolve FDA investigations, and comply with research, labeling and marketing, and other requirements for their products and services.

Health information technology companies, digital health and telehealth providers of all sizes turn to Nelson Hardiman to ensure that their businesses are protected from risk in all aspects of federal and state law governing licensing, operations, and reimbursement. We have unparalleled experience developing compliant business models, and helping clients stay in compliance to grow their businesses safely. By assisting with the business and regulatory challenges of the emerging health technology industry, we protect valuable intellectual property and products.

Nelson Hardiman’s thought leadership around the future of healthcare has driven many next-generation healthcare concepts to realization. The convergence of healthcare and the internet opens up a world of possibilities and a vast array of legal issues. Our leading role in the digital health transformation ideally positions Nelson Hardiman to help digital health providers comply with the complex web of federal and state regulations to achieve their business goals.

The seasoned professionals on our healthcare team focus on every aspect of digital health – from protection of intellectual property, to regulatory issues and privacy concerns. In an industry that is a hotbed of opportunity, we counsel start-ups, inventors and innovators on the business and regulatory drivers of innovative digital business models, including mHealth, telehealth and other modalities, making Nelson Hardiman the one-stop law firm for digital health.

Our Work Includes:

  • Business Transactions Advise on the formation of professional corporations and management companies.
  • Compliance Advise on corporate practice of medicine, licensing, internet prescribing, Stark and Anti-Kickback and HIPAA requirements.
  • Compliance and Risk Management Strategy Advised a digital health company on compliance and risk management strategy in servicing Medicare beneficiaries and contracting with Medicare and in-network healthcare providers.
  • Digital Health Proactively counsel digital health providers to meet business, regulatory and strategic challenges from mobile digital health platforms to internet prescriptions.
  • Litigation Defend licensure, Medicare/Medi-Cal and DEA defense and appeals, False Claims Act/qui tam whistleblower litigation and general business disputes.
  • Regulatory Compliance Advised on potential fee-splitting, anti-kickback, and other regulatory issues involved in third-party website referral services.
  • Regulatory Defense Represent digital health providers in medical Board investigations, DEA audits/investigations and reimbursement audits.
  • Telehealth Keep telehealth providers current with laws, regulations and agency guidelines in California and across national platforms.

Immersed in the strategic ideas and innovative concepts of health information technology (HIT), we advise on the ever-changing regulatory landscape and emerging industry trends to help our HIT clients optimize billing practices, enhance the patient experience, optimize safety, and protect data privacy while making healthcare more accessible for everyone.

Our skilled team of healthcare attorneys proactively counsels HIT providers on the shifting federal, state, and local agency laws that comprise the regulatory framework for health information technology. We are legal strategists who resolve complex regulatory issues and address financial and operational concerns as HIT innovation continues to transform the healthcare industry.

Our Work Includes:

  • Business Advise on transactions including the formation of corporations and corporate governance, purchase, sale, business associate and data-handling agreements, and HIPAA contracts.
  • Compliance Experienced with HIT incentives, Stark and Anti-Kickback Statute, HIPAA and state data privacy and security requirements, data breaches and patient notification, e-Prescribing, electronic medical records, and operational policies and procedures.
  • Litigation Defend business and employment litigation and provide lawsuit defense.
  • Regulatory Defense Provide representation in Medical Board investigations, DEA audits and investigations, reimbursement audits and investigations by private and government payors.