What are blockchains and how they are applied within the medical industry

It is well known that with the introduction of a new continental regulatory system, the regulatory requirements that protect the after-sales surveillance of medical devices (PMS), have become increasingly complex and rigid by the Health Authorities; in fact, the amount of mandatory data that must be analyzed, has grown exponentially over time, allowing us to better understand the evaluation of the safety of medical devices.

In the face of this evolution of the regulatory environment, new emerging technologies within the biomedical and medical sector, such as blockchain and artificial intelligence, have been analyzed and introduced.

The blockchain (chain of blocks) is a decentralized, shared and immutable data structure, which exploits the characteristics of a computer network distributed over several nodes, allowing to guarantee greater security, without using a central control and verification entity; The fact that it does not use of a central structure, leads to the need to obtain consensus from all nodes, in case you want to make changes to the register.

More specifically, they are a chain of blocks or sequential packets, which contain cryptographically protected data within them. The technological application guarantees the maintenance of data integrity, introducing new measures that preserve the authenticity, anonymity and instant use of the same.

This technology was developed around the end of 2008 by an unknown inventor who presents himself under the pseudonym of Satoshi Nakamoto, the original purpose was to use it as a basic infrastructure for Bitcoin, that is the famous cryptographic virtual currency circulating on a computer network without intermediaries (peer-to-peer) and managed by specific algorithms.

Only in 2014, academics turned their attention to such technology that had allowed the development of bitcoin, the blockchain precisely, to use its great potential in other contexts, thus gradually encouraging the development and experimentation of this data structure by different companies, operating in various sectors, including the medical one.

In the latter sector, thanks to this innovative technology, the centralization of databases, which causes an incomplete and often anchored sharing of information, and the complicated management of the patient privacy are being overcome.

Deepening the different applications of Blockchain on medical devices it is not difficult to see the additional advantages to which they have led. In the case of electromedical or medical devices, for example, which transmit and store patient-specific data, this technology is used to prevent such data from being maliciously breached or intercepted during transmission; all this thanks to the cryptographic protection, which makes data immutable and private, which is not always possible with the traditional storage and transmission processes.

The aforementioned technology also allows you to store in a simple and effective way the clinical history of patients, and the patients themselves, can have full access and control of their information, also having the possibility to choose with whom to share it. Globally, full access has been achieved, in real time, to information regarding diseases and the effectiveness of treatments, thus simplifying the prevention of errors by doctors. significantly impacting, on prevention, on the success of treatments and on the control of approach errors.

Blockchain is also used for maintaining permanent records related to the design, manufacture, and distribution of medical devices and components. For example, a Bill of Materials (BOM) is stored for each medical device, and each vendor must place each record within the blockchain blocks, but only in the approved parts, with predetermined mechanisms, and compliant with the regulatory specifications.

A very important feature of these technologies allows permanent traceability for each device, allowing also the identification of any counterfeits; this is thanks to the fact that once the information is sent to a blockchain, it can no longer be modified in any way.

Through blockchain applications it is also possible to share the operational information of electromedical devices with maintenance managers, preventing sensitive data from being breached, and keeping records such as Audit Trails.

Last but not least, these technologies allow the medical device manufacturers to share design data with the regulatory organizations, which are given the opportunity to constantly monitor compliance with the regulations or guidelines signed contractually by customers, to which these products are subject. In this way it is possible to follow the life cycle of each medical device, from conception to marketing, verifying regulatory compliance at all times.

Although the blockchain can be considered a substantially secure system, objectively it still has several limitations, including the security, energy consumption and memory capacity of the servers involved in the chain, but also that it can be brought to saturation by a continuous increase in the number of information inserted within the “chain”, thus giving rise to the need to introduce more performing processing systems and a scalable processing capacity.

That said, it is not only plausible but almost certain that this is the future direction and that if it has already allowed a considerable leap in quality, it gives a glimpse of a formidable potential with improvement impacts even difficult to imagine today.