regulated under the Clinical Laboratory Improvement Amendments (CLIA),^78
whose provisions concern laboratory and the so-called home-brew tests. They are
focused not on equipment but on service provided by the reference clinical labora-
tory. FDA is currently proactively searching for a clear regulatory framework in the
field of personalized medicine. Genetic testing should be conducted exclusively
within the framework of CLIA in order to obtain reliable and accurate results and
strengthen the public confidence in testing.
After the 2010 reforms and amendments of the previously mentioned basic
legislative instruments, especially HIPAA, HITECH, and GINA, it can be con-
cluded that regulatory framework needs adjustments and further development in the
field of information protection and patient privacy. Having in mind the role of the
FDA in the process of application of personalized medicine in the United States,
FDA Commissioner Margaret Hamburg highlights the key phases in the further
development of personalized medicine. Apart from the already mentioned FDA
Guidances, she points to the strengthening of cooperation with other agencies, as
well as the legally most important part of the process—its transparency.^79
The above concerns the entire operation of subjects conducting genetic tests,
medicines producers, and health care providers (especially regarding the applica-
tion of genetic tests and administration of medication, whose efficiency is dictated
and established by test results).
When analyzing the concept of transparency, it is necessary to regulate the
system and cost reimbursement procedures for personalized medicine. Problems
and limitations arise with the application of differing procedures by competent
authorities and local entities. By removing these obstacles, a patient is given full
access to personalized medicine.
Elimination of barriers and transparency of procedure is achieved through
clearly defined regulatory framework. Laws and regulations in this field should
be based on full comprehension of the entire process, from laboratory testing,
diagnostic procedures, administration of medicines to patients and cost reimburse-
ment. Only time will tell whether the responsibility and potential civil liability^80 for
not recommending or not applying certain pharmacogenomics or genetic research
by the doctors before administering treatment can accelerate the development of
regulatory framework in the United States.
Precision Medicine ( 2015 ).http://dukepersonalizedmedicine.org/policy/regulatorylegal. Accessed
20 Jan 2015.
(^78) TheCenters for Medicare & Medicaid Services (CMS)regulates all laboratory testing (except
research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amend-
ments (CLIA). In total, CLIA covers approximately 244,000 laboratory entities. See more at
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect¼/clia.
Accessed 10 Jan 2015.
(^79) Vogenberg et al. (2010a), p. 631; Rugnetta and Kramer ( 2009 ).
(^80) See more on this issue, e.g., Marchant et al. ( 2006 ).
Challenges of Personalized Medicine: Socio-Legal Disputes and Possible Solutions 47