Security and information governance
Bleepa is a secure, encrypted, zero-footprint application, meaning that no patient data is stored locally on any device. It is manufactured using processes that adhere to the ISO 13485 quality standard, ISO 27001 information security and Cyber Essentials Plus security standards.
It is the only communications platform on the NHSX clinical communications framework to be certified as a CE marked medical device for undertaking medical image review.
Background
Bleepa has evolved from PACS and has been developed by the leading medical device manufacturer Feedback Medical Limited, which has a long-standing history with clinical medical imaging.
Bleepa is powered on a fast, scalable and secure cloud infrastructure, it is compatible with existing PACS frameworks and is easy to install and implement. It is a regulated, safe and proven communications imaging tool.
It can be used for multi-disciplinary team meetings and offsite access to imaging meaning that you don’t need additional web PACS licences from your current PACS vendor, saving you money and allowing flexible working for your clinicians.
Secure clinical communication
Guidelines set by the MHRA state that clinicians and hospitals, when making decisions on patient care, are meant to use medical devices with a CE mark, representing that the device has met the legal requirements for safety, quality and performance.
Regulations enforced by the CQC also require that there is an “accurate, complete and contemporaneous” record of care. So if key clinical decisions are not captured in the electronic patient record – because they had been taken using a separate messaging system – then that record is arguably not complete and accurate, putting a care provider at risk of action from the regulator.
- Bleepa is a CE marked medical device meeting the appropriate MHRA guidelines.
- Bleepa’s links to a trust EPR mean decisions taken using the platform are recorded in the patient’s core record.
- Bleepa’s unique high-quality imaging capability also mean it is appropriate for sharing and reviewing images.
Watch our Digital Health webinar below on compliant, safe and secure clinical messaging to find out more about the importance of using the right device for image sharing and clinical decision making.
ISO certificates
At Bleepa we ensure our products and processes are of a high standard and comply with the laws and regulations of the medical device industry.
We produce and manufacture our products within an ISO 13485 Quality Management System (QMS). Our QMS incorporates the EU requirements for medical device manufacture as well as the needs of U.S Medical Device regulation (21 CFR 820). We have the capability to produce medical image analysis software products that satisfy the needs of 21 CFR 11 and HIPAA.
We also have a certification for ISO 27001 for data management security. ISO 27001 is the international standard that outlines the requirement for an information security management system (ISMS). Its best-practice approach helps organisations manage their information security. It does this by addressing people and processes, as well as technology.
Our CE mark
Our CE mark demonstrates the stringent criteria we have met in manufacturing our device.
All clinical communication platforms that display digital images of patients for the purpose of diagnosis are classed as medical devices under the Medical Device Directive (MDD) guidelines and require a CE mark. Bleepa is the only communication platform to address the UK market that has met MDD certification requirements.
Using non-CE marked products inappropriately may put individual clinicians and trusts at risk of civil claims for damages arising from misuse of that product. Therefore, the MHRA advise that all providers only use appropriately CE marked devices.
Cyber Essentials Plus certificate
The Cyber Essentials Plus audit is a government backed scheme that protects organisations from a range of the most common cyber-attacks. Our Cyber Essentials Plus certificate demonstrates our commitment to cyber security.
