Medical Device Safety
Answers for Patients
Why should I care about medical device safety?
Because your life may depend on it. Even if you have high medical device standards in your own country, you may travel to another country with a different quality level. The goal of MedReg is to establish the highest possible quality standard for medical devices in all countries, both in regard to safety and also in regard to the security of your data which may originate from a medical device and then be stored on the secure MedReg Blockchain. Most importantly, your existing medical data may be used by a device and the outcome of your treatment - and potentially your life - may depend on the integrity and accuracy of the data that is supplied to such medical devices.
What is MedReg?
MedReg refers to The International Organisation for Medical Device Regulation Compliance, Patient Safety and Blockchain Security (MedReg International or MedReg), a Swiss non-profit organisation.
Isn’t there already an organisation of governments that works on global standards for medical devices?
Yes, the International Medical Device Regulators Forum (IMDRF) works on harmonisation of regulations in participating member countries.
Why is there a need for MedReg?
MedReg develops security standards specifically for Blockchain technology and Smart Contracts to make medical devices safer.
What other benefits does MedReg create for patients?
Currently, different regulations and quality systems in most countries create an enormous administrative burden and cost on regulators, health authorities and medical device manufacturers. This cost is ultimately passed on to hospitals, governments, insurance companies - and ultimately patients. MedReg works on standardisation of international regulations with the help of Blockchain technology and Smart Contracts.
Blockchain and Smart Contracts
What is a Blockchain and why is it the best choice for medical device safety and data security?
A Blockchain refers to blocks of data that are duplicated onto a large number of servers. The advantage of this system is the fact that any manipulation of data on one server can be automatically detected by checking the same information on other servers of the Blockchain. You could compare it to laws in a book that is distributed to all citizens. If one tried to alter a page, all other citizens could check their version of the book to detect the modification in another. IT systems are particularly secure when they use a consortium blockchain where all components are standardised and “open” for security inspection, ranging from microprocessors to firmware, operating systems, apps and the network itself. The opposite of “open” would be a “proprietary” system that is typically owned by one IT vendor and not open for inspection.
What is a Smart Contract?
A “Smart Contract” is software that executes commands automatically on the Blockchain. Usually Smart Contracts refer to fully autonomous programs, also known as “unstoppable applications”. The intent of such applications is to prevent interference by third parties.
What are the dangers of fully autonomous Smart Contracts?
Traditional Smart Contracts cannot be stopped. This can be desirable to prevent interference but it can also have severe consequences if programming errors (developer bugs) are included in their code or if hackers find a way to launch a Smart Contract on a Blockchain that can manage important resources.
What type of Smart Contracts does MedReg use?
For security reasons, MedReg is only using semi-autonomous Smart Contracts. These are Smart Contracts that can be stopped by health authorities and designated administrators with proper authorisation.
Do “semi-autonomous” Smart Contracts not defeat the purpose of an independent Blockchain?
No. Semi-autonomous Smart Contracts do not affect the independence of the Blockchain. The Blockchain itself records information in a way that it cannot be altered and MedReg does not allow any party, including health authorities, to modify historical records on the Blockchain. However, Smart Contracts can execute a lot of tasks automatically, e.g., processes for medical devices. If a Smart Contract is considered a risk, then there must be a possibility to stop this Smart Contract - or even better - its execution must not be allowed at all unless it has been inspected and has proper authorisation. This is why MedReg prohibits fully autonomous Smart Contracts on its Blockchain.