Partnerships 2010: New Era of Privacy Concerns for Drug Development: Business Implications for Sponsors and CROs

Moderator: Douglas Peddicord, PhD, Executive Director, ASSOCIATION OF CLINICAL RESEARCH ORGANIZATIONS (ACRO)
Panelists: Carl de Moor, Senior Director, Health Outcomes, PPD, INC.
Eric Gemmen, Senior Director, Medical Affairs, Epidemiology & Outcomes Research, Late Phase & Safety Services, QUINTILES

An overview was provided that addressed the issue of the privacy of one’s health information and the desire for Comparative Research. Central to this debate are the conditions set forth with the HIPAA Guidelines and the American Recovery and Reinvestment Act (known as HIPAA2).

A detailed discussion dealt with the content of what HIPAA covers with respect to the rights that individuals have with their health information and the manner in which human data can be obtained/used for comparative research purposes. Distinctions were made regarding the use of information that can be used versus that which can’t be used and what remuneration would be allowed to obtain such information.

A review of the ARRA 2009 reveals that there is a new emphasis on the protection of health information that is encrypted, which will limit (protect) the use and disclosure of said information. There seems to be a new era of enforcement in the dissemination of this information as there is increased compliance directives as well as increased penalties for violating these directives.

In the event there is unauthorized use of one’s health information, there are certain requirements that need to be met in the reporting of this violation. This involves notifying the individual involved within 60 days in writing and to notify the HHS in the event data from more than 500 people have been affected. The FCC is also involved in the privacy and security issues associated with one’s health information.

Comparative effectiveness research efforts will use certain types of subject information. This would include age, gender, service dates, geography, medical condition, type of therapy, procedures, labs and other demographics. Research networks will also contribute to the collection of this information.

The impact of HIPAA and ARRA on the R&D industry is not fully known. Government information (HHS) was to have been released in February 2010 to address this issue but this release date has been delayed. Only when the government position on these issues is known can a determination be made regarding the extent of the impact on the pharmaceutical and biotech industry.