Christine Moundas

Experience

Privacy, Security, and Breach Advising

• Advising a wide array of health care players, both covered entities and business associates, on structuring and implementing HIPAA compliance programs and risk assessment processes.
• Coordinating incident response and breach analysis activities for large cybersecurity incidents as well as more routine security and privacy incidents impacting health care clients.
• Guiding response to several HHS Office for Civil Rights HIPAA compliance audits and investigations.
• Advising pharmaceutical companies, device manufacturers, and digital health companies on privacy and security issues impacting their industries. 
• Structuring and advising quality improvement collaboratives engaged in complex data exchange and benchmarking activities as well as related research initiatives, including statewide quality improvement initiatives in multiple states.

Digital Health

• Advising Electronic Health Record (“EHR”) vendors, Health Information Exchange (“HIE”) entities, HIE vendors, Health App providers and other digital health companies in navigating complex regulatory issues, including certified EHR technology requirements.  
• Counseling large health systems and other health care providers on the EHR Meaningful Use program requirements and assisting with response to numerous related audits.
• Advising a leading academic medical center in connection with the negotiation and implementation of an enterprise-wide EHR system.
• Assisting with development and review of Health Apps and portals, including terms of use, privacy policies, vendor agreements, consents and authorizations.
• Advising medical device manufacturers and start-ups on regulatory considerations related to proposed Artificial Intelligence (“AI”) applications in the health care space.  

Health Care Transactions

• Representing large health systems in major transactions, including for-profit mergers and not-for-profit affiliations.
• Advising private equity companies in investments in health provider entities and health care companies, including digital health companies.
• Guiding private equity, for-profit and tax-exempt clients through health care due diligence, regulatory and reimbursement issues.
• Advising long-term dialysis joint venture in multi-year expansion.

Health Care Compliance and Operational Advice

• Advising on Medicare and Medicaid compliance and reimbursement matters, including SNF-PPS, PQRS and MACRA requirements, reimbursement appeals, medical necessity audits, etc.
• Assisting with complex licensure and certification matters, including termination proceedings. Developing complex plans of correction for significant CMS survey statements of deficiencies, and assisting with Systems Improvement Agreement negotiations with CMS.
• Overseeing many New York certificate of need applications for various facility types, including hospitals, dialysis centers, adult care facilities and assisted living residences.