The protection of patient data is a top priority at mProve Health. Since our company is focused exclusively on clinical systems within the life sciences field, our entire architecture is designed with data protection in mind. Our systems are designed to meet the expectations of HIPAA, 21 CFR 11 (and other pertinent regulatory provisions), and EU data privacy directives.
In our partnership with the largest CROs and Sponsors in the world, our Quality System has successfully met with approval by numerous auditors and quality assurance reviews. We have a comprehensive suite of SOPs and physical/logistical security measures to safeguard patient data included within our system. These SOPs are designed to meet ISO and NIST quality/security standards. Accordingly, mProve has received U.S.-EU (and US-Swiss) Safe Harbor certification, from the U.S. Department of Commerce. This certification confirms that our quality and data protection standards meet (or exceed) the EU data privacy standards.
We employ a team of external advisors and internal staff to ensure that our quality system and data protection meet the expectations of the regulatory landscape. Given our base of operations in Washington, DC, we are actively involved in the mHealth Regulatory Coalition, and are working with industry and government officials to advise the FCC/FDA, as well as the US Congress and help shape their regulatory framework for the emerging mHealth field.
Data protection is paramount at mProve Health. Please contact us to receive a copy of our Data Protection Statement.