Life Sciences and Healthcare

Big Data

Industry-Specific Issues

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Experience

  • Negotiate data-sharing agreements among collaborators in life sciences research projects.
  • Advise covered entities and business associates on Health Insurance Portability and Accountability Act (HIPPA) privacy, security and breach notification compliance requirements.
  • Guided a large pharmaceutical manufacturer through its implementation of Medicare Secondary Payer reporting.
  • Implemented internal guidelines for a pharmaceutical company to track and report payments to physicians and teaching hospitals under the Open Payments provisions of the Physician Payment Sunshine Act.
  • Advised a provider of a direct-to-consumer personal health record solution on the regulatory considerations affecting such entities that operate outside of the HIPAA regulatory regime.
  • Advised a state-sponsored operator of a health information exchange on its federal Department of Health and Human Services grant funding agreement and related compliance requirements.
  • Advise biotech clients on the licensing of data and technology from federal agencies such as the Centers for Medicare and Medicaid Services and the National Institutes of Health.
  • Advise software developers operating as business associates on the contractual, intellectual property and regulatory considerations involved in conducting data aggregation and de-identifying and using health information for secondary purposes.
  • Advised on the patent eligibility of algorithms, software and methods of analysis relating to genetic data.
  • For software startups in the healthcare sector, developed standards for ensuring that HIPAA-covered information is secured, while ensuring that information is de-identified in accordance with HIPAA standards.
  • For a clinical research sponsor, negotiated a clinical trial agreement that protects the sponsors' rights to receive and use clinical data within the scope of the institutional review board–approved informed consent.
  • For pharmaceutical companies, advised on foreign and domestic privacy and data protection issues in the context of document production in patent litigation.
  • For a large account servicing organization, conducted regulatory due diligence review in the acquisition of a health claims processing company.
  • For a nonprofit healthcare provider, investigated and coordinated the remediation, individual notification and regulatory reporting stemming from a loss of computer media containing unsecured health data.