Originally Published MX November/December
2001

GOVERNMENTAL &
LEGAL AFFAIRS

Global Data
Privacy and Security

Part
2: The Impact of Privacy Laws on Medical Product Development

By implementing
privacy and security programs, medtech manufacturers can turn compliance with
patient data laws into a competitive advantage.

Edward J. Green
and Lisa J. Acevedo

In
the United States and abroad, public concern about the privacy of personally
identifiable health information has led to a variety of new laws and regulations
governing the use and disclosure of personal data.



The first installment
of this article (MX, September/October 2001) provided an overview
of both U.S. and international laws governing data privacy and security, including
the Health Insurance Portability and Accountability Act (HIPAA), the European
Union’s Data Privacy Directive, and U.S. safe harbor principles.^1-3
This installment offers practical tips on how medtech manufacturers can effectively
meet data privacy and security legal challenges, avoid pitfalls, and use these