Debra R. Fiala

(402) 231-8750
Partner
(402) 346-1148 Fax
Debra.Fiala@KutakRock.com

Ms. Fiala, M.D., J.D., works in the health care group in the firm's Omaha office. She has served as counsel on compliance, regulatory and operational matters for hospitals, health systems, physician practices, pharmacies, laboratories, and ancillary health care providers. Dr. Fiala routinely advises clients on matters of health information privacy and security including matters involving the HIPAA Privacy, Security and Breach Notification Rules, state health information privacy and security laws, clinical and research data transfers (e.g., clinical and research registries; transfer of records in health care acquisitions), and electronic health records.

In addition to health care-related matters, Dr. Fiala has significant experience in federal and industry-sponsored research and programs including contract matters, material transfer, grant administration, regulatory compliance (IRB, IACUC, IBC, radiation safety, conflict of interest), accreditations, research misconduct and federal agency relations (OHRP, OLAW, USDA, FDA, ORI, OIG). Her practice is informed by her medical education, experience as a practicing pediatrician, and service as in-house counsel and compliance director for an academic medical center located in the Midwest.

Recent engagements have included:

  • Drafting template business associate agreements for a health system.
  • Advising a business associate on developing a HIPAA compliance plan.
  • Advising a health system to develop an integrated health record with community physicians.
  • Advising a health system to implement telemedicine initiatives.
  • Assisting a physician practice in the return and reporting of a Medicare overpayment.
  • Assisting an academic medical center on policy review and drafting including privacy, physician contracting and organ donation policies.
  • Assisting a client with a drug diversion matter.
  • Advising a client to form a Medicare ACO.
  • Advising a client on compliance with a state-sponsored grant.
  • Reviewing and negotiating sponsored research contracts for a health system.