The company leads in data privacy and security, achieving another industry landmark as the only eCOA and ePRO provider with compliance across all regulations
14 October 2014 – Exco InTouch, the leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, today announced that it has emerged as the first organization to comply with Safe Harbor, EU Data Protection and HIPAA (Health Insurance Portability and Accountability Act), providing the highest standard security and data privacy for patients. The company is the only electronic Clinical Outcomes Assessment (eCOA) and electronic Patient Reported Outcomes (ePRO) provider with the capability to physically separate Personally Identifiable Information (PII) needed to comply with data privacy and security regulations. Exco InTouch’s mDNA® proprietary technology segregates PII, enabling data to be handled in compliance with all the above regulations.
Complying with data privacy and security regulations is essential for delivery of a BYOD (Bring Your Own Device) approach, whether it is being applied to eCOA data capture, or by programs designed to engage patients in a clinical trial or health regimen. A key attribute of Exco InTouch’s technology, which complies with FDA guidelines (21 CFR Part 11), is its two factor authentication process that provides increased confidence that the data has been entered by the patient – through a combination of possession of device and knowledge of the access code. It also has the added benefit that the data points are fully traceable and attributable to the source as set out in the FDA eSource Directive.
Tim Davis, CEO and founder of Exco InTouch commented: “The strategy to use patients’ own devices has been one of our core principles ever since the company was founded. Indeed, this has enabled us to design safeguards for data privacy and security into the heart of our technology to ensure that the highest standards of data security and safety are provided.”
Exemplifying the company’s robust credentials, alongside complying with all key regulatory frameworks, Exco InTouch is also the only eCOA provider to have published native apps on across all major mobile operating platforms, including iOS, Android and Windows8, what thereby completes the company’s holistic approach to mobile data capture. Furthermore, Exco InTouch’s recent certification to ISO9001:2008 provides additional reassurance in the quality of the processes and services offered by the company.
Due to multiple, complex and varying regulations across geographic territories, full compliance with HIPAA, Safe Harbor and EU Data Protection requirements is central to safeguarding data privacy in clinical and commercial health services. This provides confidence for patients that their data will be safe, which, most crucially, reduces a major barrier to enrollment in multi country programs. The advent of global clinical studies has meant that sponsors need to consider the legislation that vendors are expected to adhere to in order to provide the level of confidence to all stakeholders. Therefore sponsors should ensure that the vendors they contract with abide by the respective legislation that governs their main place of business, i.e. Safe Harbor if contracting with a US legal entity and expecting to collect EU patient data, and EU Data Protection if the vendor is based within the EU member states and collecting EU member states’ patient data.
Dale Jessop, CTO at Exco InTouch commented: “Protecting patients and their data has always been of primary importance to Exco InTouch. Consequently, we keep up to date with technological advances across many industries to aid product innovation and data protection and security is a key component of that – it doesn’t impede innovation. Quite the reverse, we see it as a highly important component to our service offering.”
For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 203 6740 or e-mail: t.jervis@defacto.com.
-ENDS-
About Exco InTouch
Exco InTouch is the leading provider of digital patient engagement and data capture solutions for clinical research and healthcare providers. Using a combination of software and services, Exco InTouch solutions provide simple, secure channels of communication; facilitating the collection of quality data and improving outcomes for sponsors, clinical research organizations, sites and patients.
Working across clinical and late phase trials and mHealth programs, Exco InTouch’s device independent approach enables involvement which integrates into daily life - resulting in motivated and compliant patients, reducing costs associated with withdrawals from trials and improving overall program results.
Since 2004, Exco InTouch has engaged with over 900,000 subjects across 85 countries, over 15,000 hospitals and clinics, in 70 languages. 16 of the top 20 pharmaceutical companies have deployed our trusted applications in the knowledge that data is secure and protected, in line with global regulatory and data protection requirements.
Help employers find you! Check out all the jobs and post your resume.
