Digital Health
Kristi has an active digital health practice advising
healthcare startups on the appropriate business
structuring and strategy to navigate complex and
multijurisdictional regulatory challenges. Her
background in privacy and security, licensing,
reimbursement, fraud and abuse, and corporate practice
of medicine provide her with the unique skillset to
effectively guide her clients through the various legal
and business obstacles confronting companies looking to
develop and implement telehealth, mobile health,
artificial intelligence, virtual and augmented reality,
and other innovative health technologies.
She has assisted clients in the development of regional,
national, and international telehealth and mobile health
programs and has advised health systems and life
sciences manufacturers on digital health strategy and
implementation. She has also advised private equity
sponsors with respect to digital health ventures and
health IT acquisitions.
Healthcare Compliance, Investigations and Regulatory
Counseling
Kristi has developed comprehensive compliance programs
for a variety of healthcare providers and suppliers,
including hospitals, physician practices, laboratories,
DMEPOS suppliers, IDTFs, medical device manufacturers
and specialty pharmacies. She also advises on day-to-day
healthcare regulatory and compliance matters confronting
providers and suppliers in the healthcare industry.
Kristi has developed and provided specialized training
to her client's workforces and sales teams concerning
fraud and abuse, privacy and security, and other client
risk areas. In addition, she has served as an
independent compliance reviewer for entities under
Corporate Integrity Agreements.
She advises clients on fraud and abuse matters including
Stark and Anti-Kickback as well as state law
equivalents, HIPAA, reimbursement and billing, licensing
and corporate practice of medicine issues. She assists
clients with respect to internal investigations and
self-disclosure and refund obligations and has further
represented clients under investigation by various
federal and state agencies, including the Centers for
Medicare and Medicaid Services, the Office of Inspector
General for the US Health and Human Services, the Health
and Human Service Office for Civil Rights, the Health
Resources and Services Administration, the Virginia
Department of Health, the North Carolina Department of
Health, various Virginia professional licensing boards
and the Washington, DC Board of Medicine.
Kristi represents healthcare industry clients and
stakeholders with respect to privacy and security
matters, including the development of HIPAA compliance
programs, website privacy policies and terms of use,
breach investigation and reporting, government
investigations and healthcare privacy and security
matters arising during the due diligence process. She
has also defended providers in investigations by the
Health and Human Service Office for Civil Rights. She
advises clients on compliance issues related to big
data, health information technology, business associate
agreements, data use agreements, and the use of
de-identified data.
Healthcare Transactions
Kristi advises private equity sponsors in their
healthcare acquisitions and divestitures, and the
on-going representation of their healthcare portfolio
companies, regarding healthcare regulatory issues
identified in due diligence, including fraud and abuse
matters (Stark, AKS, FCA), HIPAA, licensure matters, and
Medicare and Medicaid billing issues.
Her experience spans a wide range of specialty areas
including health IT, specialty pharmacy, laboratory,
hospitals, hospice, home health, ASCs, IDTFs, physician
practice groups and specialty practices such as
cardiology, dermatology, orthopaedics, physical therapy,
ophthalmology, oncology, urology, radiology, and
dentistry.
