Melissa K. Bianchi
PartnerWashington, D.C.

Biography
Melissa Bianchi leads the firm's digital health initiative,
bringing together a cross-disciplinary approach todigital health products such as mobile apps, wearable
sensors, and other health IT solutions. Well versed inhealth privacy law, she helps clients navigate a range ofcomplex health data issues under the Health Insurance
Portability and Accountability Act (HIPAA) and otherU.S. laws.

Phone

Melissa advises companies and academic medicalcenters on cutting-edge clinical research issues, genetic
information, and tissue and data repositories. She
handles health information exchange and meaningful
use issues for hospitals and their vendors, and works
closely with a number of academic medical centers on
structuring research activities under HIPAA, managing
student health centers, and general HIPAA compliance.

Practices

Melissa understands the health data issues unique tobiotech and pharmaceutical companies. She also has a
deep knowledge of – and speaks extensively about –prescription drug coverage under health reform andMedicaid expansion. Since passage of the Medicare Part
D program, she has been advising drug companies oncoverage issues and also helps health plans withcompliance.

Representative experience
Outside privacy counsel to a global pharmaceuticalcompany on social media recruiting of clinical trial
participants.

+1 202 637 3653

Fax
+1 202 637 5910

Emailmelissa.bianchi@hoganlovells.com

HealthPrivacy and Cybersecurity

Industries
Life Sciences and Health Care

Areas of focus
Digital Health
Clinical Trials
California Consumer Privacy Act
Health Privacy and Cybersecurity
Artificial Intelligence
Inflation Reduction ActAdvise biotechnology company on use of mobiledevices in clinical trial and ongoing patient supportprograms.

Education and admissions

Policy advisor to large trade association on healthreform and Medicaid prescription drug coverage.

J.D., Stanford Law School, 1999
A.B., Harvard University, magna cum
laude, 1992

Representing a large health information technology
company on privacy, data sharing, contracting, and data
breach management.
Advises academic medical center on clinical trial data
breaches.
Representing pharmaceutical companies and providers
in matters involving Medicare prescription drug
coverage.
Conducted privacy assessment of online information
practices for a Fortune 500 global pharmaceuticalcompany.
Primary outside counsel to major university on HIPAAand clinical research compliance.
On behalf of major trade associations and individualclients, advocated for meaningful prescription drug
coverage under health reform.
Advised multiple universities on structuring compliancefor student health centers.
Advise major pharmaceutical company in assessmentof privacy compliance in patient support programs.

Awards and rankings
Healthcare: Health Insurers, Legal 500 US, 2014
Technology: Data Protection and Privacy, Legal 500
US, 2013 - 2014
Outstanding Young Healthcare Lawyers,
Nightingale's Health Care News, 2009

Latest thinking and events
Hogan Lovells Events
CLENews

Education

Bar admissions andqualifications
District of Columbia
California (inactive)

New FDA clinical trials guidances promote efficient
drug development, innovative designs, diversity
Hogan Lovells Events
Hogan Lovells APAC Life Sciences and Health CareWebinar Series - Spotlight on the U.S. - Session 4News
Panelists discuss European pharmaceutical trends
and how to stay ahead of the game
News
Federal court strikes blow to expansive OCR web
tracking position
Hogan Lovells Events
Life Sciences and Health Care Horizons 2024