Blockchain technology introduces new secured measures for keeping authentic and anonymously real time personal data in decentralized manner. It can be expected that upon maturity the blockchain technology behind Bitcoin will gain the required trust and be used extensively by partners of the highly regulated healthcare ecosystems: patients, regulators, clinics, pharmacies, insurers, laboratories, technology developers, etc.

The healthcare system is a slow adopter of new technologies. In many North America’s clinics we can still see extensive use of paper-record based patient data. The clinics’ centralized data is not shared even within the same hospital and even for research purposes. Patients’ privacy, health records authenticity and commercial considerations are the leading factors of slow adoption of new technologies. Blockchain will become healthcare’s underlying technology that will focus around patients and diseases:

• Patients will have full access and control on their data and how it will be used and shared
• Local and global health authorities will have full control on real time anonymous data about diseases and the effectiveness of treatments

Many already agree that Blockchain technology will likely be used to:

• Store patients’ medical history
• Allow patients to control their own test results and decide with who they want to share it with
• Prevent medical errors related to medications and treatments
• Arrange financial coverage by governments and insurance companies

The availability of valuable data will also support:

• Global multidisciplinary research of new treatments
• Control outbreak of diseases by health authorities
• Contradicting effects of multiple medications research

The new technology is expected to also disrupt the development and certification of medical devices.

Regulators will leverage specific applications of blockchain allowing developers of medical devices to share secured data. Regulators could follow the life cycle of each medical device, from ideation to commercialization, ensuring that the developers follow the regulator guideline and that the medical device is safe and effectively support its intended use. Smart algorithms will support the regulator with various aspects of the approval processes to simplify the process of introducing new technologies that can save and improve patients’ lives. A semi-automated and controlled approval process will allow development companies to spend more funds on technology innovation rather on documentation and regulation processes.

A blockchain application with built in traceability functionality and electronic signature capabilities will manage Device Master Record (DMR) and the many Design History File (DHF) documents such as: product requirements, design plan, architecture and detailed design, risks, design verification and design validation.

Medical devices will be able to load patient data, validate the procedure is done on the designated patient and even share the procedure data with the patients and in anonymous way with the regulators. As regulators will have access to patients’ data, the regulator could follow on anonymous patients from diagnostics to recovery and compare different treatment regimes. By doing so regulators could provide recommendations to the public on best possible treatment and even in certain cases to forbid the use of specific medical devices that do not prove to be effective.

Manufacturing and maintenance processes will also be affected as the Device History Record (DHR) blockchain application will manage the life cycle of each manufactured medical device unit, including the collection of records created during the manufacture, service, and even during operation.

A blockchain based approval process of medical devices will ensure neutrality and will allow comparison of competing solution while keeping high standards of business ethics with regards to IP and commercialization.

The Bill of Material (BOM) of each medical device will consist only on approved parts, where each vendor will have to maintain blockchain records for each part, ensuring it meet the RoHS/REACH and other standards of the medical device industry.

Regulators will embrace blockchain to learn actual medical device effectiveness and to provide faster approvals while keeping patient safety as a top priority which is their main mandate. Regulators will have the ability to automate audits of all Class II and Class III devices and even conduct real time background audits.

As patients will be able to decide who can use their data, they will actively participate in the innovation of new medical devices and get early and free treatment options and even get a profit share. The blockchain technology will also support development of new personalized treatments, reduce treatment cost and improve healthcare quality.

Medical device companies need to be ahead of the curve and keep looking how the blockchain technology and regulators approach will soon affect the development of medical devices.

Technology acceleration will make blockchain technology mature faster than what we tend to believe.  The blockchain maturity is similar to what the internet was between 1997 and 2002. As more funds are being invested in the new technology the number of applications and tools will grow and soon we will reach the Inflection Point.

The regulators’ growing awareness to new technologies is already affecting the medical device industry. On December 7, 2017 FDA Commissioner Scott Gottlieb announced ”three new, significant policy documents to advance the FDA’s approach to the development and proper oversight of innovative digital health tools.”

The FDA realize that “clinical evidence demonstrates that consumers who are better informed about health make better and more efficient decisions, take steps to improve their lifestyles and their health choices, and often experience better outcomes”. As such the FDA will “encourage the development of tools that can help people be more informed about their health”. The FDA “lean in the direction of enhancing access to more information – not restricting information flow – given the ability of reliable information to positively impact daily life.”

The new FDA policies are:

• Clinical and Patient Decision Support Software (CDS). This draft guidance is intended to make clear what types of CDS would no longer be defined as a medical device, and thus would not be regulated by the agency.
• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
• Software as a Medical Device: Clinical Evaluation

Blockchain Technology in 150 words  Blockchain in the simplest manner is a system that lets a group of computers (also called Nodes) to maintain a copy of the same digital file (also called a ledger). The digital file can include financial transactions or other types of data update. A data update to the file is being broadcast to the system’s network and then some nodes in the network apply the data update to the ledger and then send the data update to other nodes. Because the ledger is maintained by a group of anonymous computers everyone who is connected to the system can potentially read the data updates. The system is controlled by complex mathematical formulas and rules that provide digital passwords to allow authentic data updates and data ownership. Not all the computers in a Blockchain network need to store a ledger – some can only add or read data.