Consider US-based Clinical Trials. When working in the US healthcare industry, the question of how to become HIPAA compliant arises regularly. The HIPAA regulation is written in a way that is confusing to most healthcare professionals, without clear guidelines on what exactly needs to be done in order to become HIPAA compliant. To provide guidance on how to become HIPAA compliant, implementing an effective compliance program, and HIPAA requirements are discussed in this helpfull article presented by the Compliancy Group.
That is for US based Clinical Trials (CT) Projects, wha about the others?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) sets a series of US national standards for healthcare information used by covered entities and business associates.
Healthcare information regulated by HIPAA is called protected health information (PHI). PHI is any demographic information that can be used to identify a patient. PHI can include a patient’s name, address, Social Security Number, insurance ID number, medical record, full facial photograph, and others. Sounds familiar?
Probably because it is. We at Pearls.Clinic do believe HIPAA needs to be aligned with the GDPR.
They both obviously cover a lot of common grounds. But. GDPR is much more aligned with the reality we live in post-2020. And no CT project can avoid the scrutiny of the EU regulators.
Clinical Trials and the GDPR Compliance Post 2020
Pre 2020, the major concern over the implementation of the GDPR, which was designed with an eye on large tech firms, was that it actually gave an advantage to businesses with deeper pockets. Smaller businesses did not have the resources to comply with GDPR as easily as larger companies, such as Google or Facebook.
But post 2020 there is only one business with the bottomless pockets: Public Health.
That means Public Health institutions have run out of excuses about handling of data in general and patients private data in particular.
And after experiences of “fast-tracking” the Covid-19 vaccines, Clinical Trials are in the spotlight.
Pearls.Clinic experts are here to help. Please do contact us to discuss your data regulatory requirements. And Perals.Clinic solutions.