PHR may be extended to registers of patients, clinical investigations portals,
databases of certain illnesses, and Internet sites where consumers voluntarily fill in
the questionnaires about their health condition.
The Health Information Technology for Economic and Clinical Health Act
(HITECH Act) was enacted as part of the ARRA, with the objective of its better
implementation in practice. Its provisions address the privacy and security concerns
and prescribe financial penalties for violations of the patient’s right to privacy.
These provisions are directed at all subjects who use, process, or handle the
information about patients at all levels of the health system, including personalized
medicine and its pertaining components.
The Genetic Information Nondiscrimination Act (GINA)^74 is an act designed to
prohibit employers and health insurers to discriminate individuals based on their
genetic predisposition to develop illness. The objective of the act is to promote
genetic testing and consumer confidence in them, without the fear that the gathered
information will be used against them. According to available studies, two-thirds of
Americans believe that genetic information is potentially abused, while one-third is
not willing to take such tests or participate in research, unless legal protection is
improved.
The above shows that all information, including family case history, requires
strong and applicable protection against abuse.
Advantages of personalized medicine can be fully realized only if any possibility
of abuse is eliminated.
8.1.2 Further Development of Regulatory Framework for the
Pharmaceutical and Diagnostic Industry
It would be useful to establish joint guidelines for the development of pharmaceu-
tical and diagnostic industry, given the traditionally diverging regulation patterns,
e.g., for clinical studies or for product marketing. The American Food and Drugs
Agency (FDA) is expected to take a more flexible approach for personalized
medicine, especially for licensing procedures, adapted to targeted genome and
clinical data.
Diagnostic industry is concerned about the already adopted documents, such as
Guidance for Industry, Clinical Laboratories and FDA Staff on In Vitro Diagnostic
Multivariate Index Assays,^75 as well as Guidance on Commercially Distributed
Analyte-Specific Reagents,^76 taking into account possible increase of tests that
profile more biological subjects, such as proteins or genes.^77 Such tests are currently
(^74) The Genetic Information Nondiscrimination Act of 2008 , Pub.L. 110–233, 122 Stat. 881.
(^75) U.S. Food and Drug Administration (2007a).
(^76) U.S. Food and Drug Administration (2007b).
(^77) A valuable overview of instruments and policy papers in relation to the federal oversight of
genetic/genomic testing is provided on the Internet site of Duke Center for Personalized and
46 N. Bodiroga-Vukobrat and H. Horak