privacy A
A question of
Sophia Ktori looks at the steps taken by
informatics companies to protect patient data
ccess to confidential patient data – including medical records, test results, samples and specimens – is today inevitable in the healthcare and life
sciences sectors. Data ranging from medical records to genetic
test results may need to be viewed and passed between clinicians and central laboratories in the healthcare sector, contract research organisations and sponsor organisations during clinical trials. Maintaining patient data security and
confidentiality is an imperative for data that resides permanently in a database behind an organisation’s firewall, in the cloud, or during transfer within and between organisations, points out Labtopia co-founder, Gretchen McAuliffe. Labtopia supplies GxP-compliant data
management solutions in laboratory enterprise and cloud environments, and is a Termo Fisher Scientific Informatics preferred reseller and implementation partner. ‘At one end of the spectrum, patient data may be sent by a simple FTP file transfer, while at the other end there are soſtware tools that can facilitate the integration of informatics platforms to make data access easier,’ McAuliffe notes. ‘Technology is progressing to cloud or web interfaces so that remote parties can see relevant information directly and securely, without the need actually tomove the data.’ Transfer of data from one desk to another,
whether via web portals, faxes or paper printouts, introduces risks in data integrity and security. And the situation is complicated because packets of data that include confidential
20 SCIENTIFIC COMPUTING WORLD
patient information, as well as sensitive data on the trial’s progress, may have to be moved between – or accessed by – a number of different parties, for different purposes.
Adhering to national regulations In clinical trials, the responsibility for ensuring the security and confidentiality of patient data lies with the sponsor organisation. ‘Finding informatics tools that will best
manage the trial workflow, and at the same time maximise security, fit in with organisational infrastructure and allow safe and secure data access and transfer, will depend on a range of factors, not least of which is the jurisdiction
in which they are working,’ McAuliffe notes. ‘Trials in different countries will need to adhere to national regulations, such as those imposed by HIPAA (Health Insurance Portability and Accountability Act) in the US, and possibly international statutes, depending on where the product will ultimately be marketed.’ To meet these manifold legal requirements,
companies and organisations handling any kind of patient data need to look at whether they have established and are adhering to adequate internal standards for maintaining patient data security. McAuliffe continues: ‘From a consultancy perspective, you have to help the organisation
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