Regulating AI in healthcare

 Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): a comparative analysis

Timely article. A must read to understand current situation.

A helpful document with the current approved technologies. 

Radiology leads the ranking:

Comparison of the situation between USA and EUROPE.

Quina porada

Regulation of Medical Devices in the United States and European Union

La lectura del darrer NEJM on es compara la regulació dels subministraments mèdics entre Europa i USA afegeix preocupació. Ja ho sabíem, però quan es posa una evidència darrera l'altra provoca sorpresa i angoixa. Des del meu punt de vista esdevenen sorprenents qüestions com aquesta:

For example, a distal protection system for coronary-artery interventions received a CE mark after a single-group study involving 22 subjects showed that the device worked as intended. In the United States, FDA approval came several years later on the basis of a randomized study involving 800 subjects, in which a clinical end point of major adverse cardiac events was used.

Vull evitar d'afegir altra informació que les dades objectives que mostra l'article, qualifiqueu la situació vosaltres mateixos després de llegir-lo. Tant sols voldria assenyalar que l'impacte potencial en el benestar d'una regulació inexistent, és tant pels que han rebut la prestació (problemes de qualitat) com per la societat que ha d'assumir el cost públic de la reparació del dany a causa d'un regulador absent. El cas de les pròtesis PIP ho exemplifica.

PS. Ahir vam poder assistir al Concert de la temporada, en majúscules. Estic parlant de Ben L'Oncle a la Sala Apolo, és clar. No tenc paraules per descriure una vetllada inoblidable, un geni amb uns músics encara més genials, una estètica cuidada al mínim detall, una posada en escena impecable. I així és com va començar:

Eurohealth

Everything you always wanted to know about European Union health policies but were afraid to ask

I have to say that I am not afraid to ask about health policies in EU because EU is basically a market. Therefore nothing to ask. Social policy is out of the real scope of EU.However, as a regulator of the market for health has clear examples of disfunctioning. For example, implantable medical devices regulation currently applied was enacted in 1990. New regulation will be applied next year, after 30 years of regulatory vacation. Nothing to add. Taxes haven't been on vacation. Shame on Europe. By the way, you'll not find minor details like this one in the book.

Is there room for healthcare in blockchain?

BLOCKCHAIN REVOLUTION: How the Technology Behind Bitcoin is Changing Money, Business, and the World

Blockchain, the technology behind bitcoin, the virtual currency, could be the new tool that could change the current state of health records and healthcare information. Up to now we have been discussing about interoperability between systems. What would happen if the citizen is the owner of the information and he has all data available everywhere anytime?. This is what certain initiatives try to define right now. Something like this initiated by the physician would be the data owned by the patient:

 

We are at the begining of a great transformation. I don't now if the appropriate word is revolution. Anyway, if you are interested in the topic you may check som details here.

However if you want a deep review of whats going on in 12 critical disruptions, read chapter 6 of the book "Blockchain revolution". You'll find there the potential impact on health:

In the health care sector, professionals use digitization to manage assets and medical records, keep inventory, and handle ordering and payments for all equipment and pharmaceuticals. Today, hospitals are full of smart devices that oversee these services, but few communicate with one another or take into account the importance of privacy protection and security in direct patient care. Blockchain-enabled IoT can use emerging applications to link these services. Applications in development include monitoring and disease management (e.g., smart pills, wearable devices to track vital signs and provide feedback) and improved quality control. Imagine an artificial hip or knee that monitors itself, sends anonymized performance data to the manufacturer for design improvements, and communicates with a patient’s physician, “Time to replace me.” Technicians will be unable to use specialized equipment if they haven’t taken prerequisite steps to ensure their reliability and accuracy. New smart drugs could track themselves in clinical trials and present evidence of their effectiveness and side effects without risk of modified results.

If you are interested in innovation and want to follow the next wave, the internet of value, then you need to read such book. Definitely, there is wide room for health in blockchain.