Compliant with healthcare regulations
Bleepa is compliant and secure, making it easy to acquire and put into practice for your team. It can be easily integrated into any existing IT infrastructure. We support standard interfaces for a smooth implementation and integration.
Our accreditations
- Bleepa is a UKCA marked communications platform incorporating medical image display, actively in use by the NHS. Review evidence
- Active maintenance of ISO 13485 certification– the Quality Management standard for Medical Device manufacture (certified since 2014). Our Quality Management System (QMS) incorporates the UK requirements for medical device manufacture to allow us to produce UKCA marked products. Review evidence
- Active maintenance of ISO 27001 certification– the Information Security Management standard (certified since 2020). Review evidence
- Fully documented and tested business continuity management processes and procedures audited as part of our ISO 27001 certification and in alignment with the requirements in ISO 22301 BCM systems.
- Certification against the UK government Cyber Essentials and Cyber Essentials Plus standards. Review evidence (Cyber Essentials) and review evidence (Cyber Essentials Plus)
- Participating in the NHS’s Data Security and Protection Toolkit scheme and aligned with the NHS Digital Technology Assessment Criteria (DTAC). Review evidence (DSPT)
- Producing products that comply with the DCB0129 Clinical Safety Standard.
- Registered as a Class A medical device with the Central Drugs Standard Control Organisation (CDSCO) in India.
Zero-footprint application
Bleepa is a secure, encrypted, zero-footprint application, meaning that no patient data is stored locally on any user device.
- Manufactured using processes that adhere to security standards
- UKCA accredited communications platform
As a UKCA marked medical device, Bleepa is certified to display clinical images at a suitable quality for clinical review, ensuring patient safety and reducing inadvertent risk for clinicians and their employers.
Certified medical device
As Bleepa is certified as a medical device for clinical results display, it supports healthcare providers to meet regulatory requirements from the Information Commissioner’s Office (ICO), Care Quality Commission (CQC), and the Medicines and Healthcare products Regulatory Agency (MHRA) for secure clinical communication.
The platform gives clinicians a common view of each patient, providing access to medical images, test results, and other clinical documents in one safe, secure environment – both on-site and remotely. Discussions can take place flexibly on a fully auditable platform, with all communications captured as part of the patient record. This reduces the documentation burden on clinicians while maintaining a complete, integrated, and compliant clinical record.
Meeting regulatory requirements
There are several regulatory requirements that NHS organisations need to comply with regarding clinical communications and patient records, all of which Bleepa complies with for peace of mind for those organisations and their IT and governance teams.
Use of non-compliant social media apps
Using standard messaging apps creates information governance concerns and breaches clinical safety regulations, resulting in a liability risk for clinicians and their employing organisation. Following the Information Commissioner’s Office (ICO) ruling, it is imperative that healthcare providers take active steps to move their clinicians onto compliant communication platforms.
Care Quality Commission (CQC) requirements
Healthcare organisations have a requirement to provide appropriate tools for facilitating clinical service delivery which includes communication platforms.
A communication platform used by frontline clinicians needs to write back to the patient’s medical record in order to maintain a ‘contemporaneous’ record (existing at the same time) for the patient and to maintain clinical safety and reduce medico-legal risks. (CQC Regulation 17(2)(c))
Medical device regulation
The MHRA requirement is that the use of digital images, such as photos or radiology images, for clinical decision making requires any platform involving them to be fully certified as a medical device. This is a matter of clinical safety to ensure that images are displayed in the right quality to avoid details being missed that could lead to the harm of the patient.
Accreditations
