"I'm going to go to the doctor’s and get my blood pressure checked." The Internet of Medical Things (IoMT) makes that sentence obsolete. Today, simple, wearable devices can carry out measurements and then send the patient’s data to the doctor via the cloud. And the IoMT can do far more complex things than that too, making life easier for both patients and doctors. At its core, the really important part is always about transferring data securely from one point to another via the cloud.
tuomi has developed software and firmware that wirelessly connects an active implant to the cloud. The implant measures vital data and releases medication into the body. Both the patient and the attending physician can communicate with the device. The doctor can access the device remotely and read out data. It is also possible to remotely control the active implant. The software and firmware were developed by tuomi in strict accordance to the requirements set down in the EU Medical Device Regulation (MDR).
Even before the MDR came into effect 2017, similar concepts were in force. But the new legislation has significantly raised the standards for data protection and data security. Among other things, devices now must be able to work with encrypted data, including cloud communication. In the cloud, data protection must also be guaranteed through permanent encryption. Medical staff can then access this data through an app. Highly secure user access ensures that only authorised persons can decrypt the patient data.
These requirements also apply to previously approved medical devices. If your devices were approved under previous legislation, adjustments may be necessary. This may affect the technical infrastructure as well as software and hardware. tuomi has already implemented all these requirements in accordance with MDR.
We will be happy to advise you on the development of medical devices that meet MDR requirements, including:
In an exceptional medical project, tuomi programmed firmware and software to enable highly secure communication between an active implant and the cloud. All of this in compliance with all legal standards, such as the EU Medical Devices Regulation (MDR) and Data Protection Regulation (GDPR) and in accordance with ISO 13485:2016.