We help manufacturers evaluate healthcare privacy compliance and support their day-to-day healthcare privacy obligations.

Many manufacturers are exposed to patient information every day. Exposure often occurs when reimbursement support is provided, when surgical cases are covered, and when company staff visit customers.

We help companies determine how HIPAA impacts their business and how to protect patient health information in accordance with the Privacy Rule among other requirements.

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Representative privacy assignments include:
  • Rendering privacy HIPAA and HITECH opinions
  • Auditing reimbursement support programs and hubs
  • Responding to requests for manufacturers to sign Business Associate Agreements
  • Reviewing drug and device manufacturer commercial field activities for HIPAA compliance
  • Helping design HIPAA-compliant marketing programs
  • Auditing DME makers for compliance with HIPAA
  • Counseling manufacturers on the application of the Treatment, Payment and Operations exception
  • Privacy training
  • Case coverage training for field staff
  • Drafting patient authorization and informed consent agreements
  • Counseling manufacturers on how to avoid becoming a Business Associate or Covered Entity
  • Designing, drafting, and implementing privacy policies and procedures
  • Creating remediation plan for breach of patient Protected Health Information (PHI)
  • Assisting manufacturers with matters involving clinical trials and use of patient data
  • Assessing the application of the Privacy Rule in light of conflicting mandated FDA requirements

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Information provided on this website is not legal advice. Communications sent to or from this site do not establish an attorney-client relationship.