Kathie McDonald-McClure leads the Firm’s Data Privacy & Security Service practice and is a member of the Healthcare Service Team. Her longtime passion for and attention to technology-related matters has given her a leg-up in assisting clients with regard to data privacy and security. She regularly advises clients on HIPAA, GDPR, state data privacy and breach reporting laws. Because data privacy has become so interconnected with cyber technology, she has become the firm’s go-to for advice on health technology agreements and the impact of the 21^st Century Cures Act (“information blocking,” “interoperability,” “patient access,” etc.).

Ms. McDonald-McClure has broad experience in the area of human research. She regularly advises healthcare providers on clinical trial agreements, research policy development, FDA and OHRP regulatory compliance, informed consent form compliance and HIPAA research authorizations, insurance and indemnification for adverse outcomes, Medicare Secondary Payor recovery issues, Medicare billing compliance, and data de-identification. She drafted U.S. contracting and informed consent templates for a global medical device company and assisted in training the company’s staff on issues that impact contract compliance.

Ms. McDonald-McClure’s career in healthcare, both in-house and in private practice, has contributed to her broad healthcare regulatory practice, which revolves around state and federal healthcare program matters with a focus on compliance and risk management. She has continuously maintained her Certification in Healthcare Compliance (CHC) by the Compliance Certification Board (CCB)® since 2007. She assists clients with enrollment and revalidation in Medicare and state Medicaid programs and with due diligence for acquisitions (including CHOWs).  She regularly advises on the Anti-Kickback Act safe harbors (with a niche specialty on the discount and rebate rules) and reimbursement issues under the False Claims Act.

In 2009, she created the Firm’s first legal blog: the Wyatt HITECH Law Blog, which originally tracked developments under the HITECH Act and Medicare’s evolving “meaningful use” program that encouraged providers to adopt electronic health records.  As the “meaningful use” program came to an end, the blog’s focus shifted to data privacy and security legal developments impacting businesses and organizations both within and outside of healthcare.

Ms. McClure’s healthcare clients include hospitals, long-term care providers, physicians, chiropractors, pharmacies, durable medical equipment suppliers, behavioral health, clinical laboratories, home health, physical and occupational therapy providers, and medical device companies. Her non-healthcare clients include community support agencies, public school districts, and colleges and universities, among others.

Jennifer Wintergerst is a member of the Firm’s Health Care Service Team and the Data Privacy and Security Service Team.  She concentrates her practice in the areas of complex healthcare litigation, investigations and regulatory compliance.  She assists clients with Medicare and Medicaid enrollment and termination issues, governmental audits and investigations and False Claims Act litigation.  Ms. Wintergerst provides guidance to healthcare clients across the industry to enable them to comply with the Anti-Kickback Statute, the Stark law, HIPAA and various Medicare and Medicaid laws and regulations.  She conducts internal investigations regarding potential overpayments and data security incidents and assists clients with the necessary reports to HHS OIG and OCR.  She also routinely represents physicians, nurses and other licensed professionals with disciplinary actions before the professional regulatory boards and assists providers with HHS OIG exclusion and reinstatement.