Melissa K. Bianchi
Melissa Bianchi leads the firm's digital health initiative, bringing together a cross-disciplinary approach to digital health products such as mobile apps, wearable sensors, and other health IT solutions. Well versed in health privacy law, she helps clients navigate a range of complex health data issues under the Health Insurance Portability and Accountability Act (HIPAA) and other U.S. laws.
Melissa advises companies and academic medical centers 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.
Melissa understands the health data issues unique to biotech and pharmaceutical companies. She also has a deep knowledge of — and speaks extensively about — prescription drug coverage under health reform and Medicaid expansion. Since passage of the Medicare Part D program, she has been advising drug companies on coverage issues and also helps health plans with compliance.
Areas of Focus
Outside privacy counsel to a global pharmaceutical company on social media recruiting of clinical trial participants.
Advise biotechnology company on use of mobile devices in clinical trial and ongoing patient support programs.
Policy advisor to large trade association on health reform and Medicaid prescription drug coverage.
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 pharmaceutical company.
Primary outside counsel to major university on HIPAA and clinical research compliance.
On behalf of major trade associations and individual clients, advocated for meaningful prescription drug coverage under health reform.
Advised multiple universities on structuring compliance for student health centers.
Advise major pharmaceutical company in assessment of privacy compliance in patient support programs.
Healthcare: Health Insurers
Legal 500 US
2013 - 2014
Technology: Data Protection and Privacy
Legal 500 US
Outstanding Young Healthcare Lawyers
Nightingale's Health Care News
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