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Healthcare AI market access and regulations: do we need a compromise?

  


Artificial Intelligence is already changing the way products and services are designed, built, and delivered to end users. Everyone can easily generate a picture or text for a product (or an entire advertisement),  code, documentation, and so on. And the level is now pretty amazing. The following is an ad copy for the product "IBM HPA" generated  by an AI with the input "technology secure compliant data computational power architecture to build services for people":


At IBM, we believe that technology should make your business more secure and compliant. Find out how we are meeting our customers' data and computing power needs with HPA.


As today's AI tools are - basically - a very good improvement on top of technologies well known by computer scientists for many years,  one may ask "what changed? why the discussion is so strong and pervasive right now?

It is probably a matter of impact.
The above ad could have been generated by a professional copywriter, artists may complain about an AI winning art contests, and musicians do already face the competition of AI-generated music on Spotify, while others enjoy the opportunity quite well. AI is now definitely out of the computer science lab and it is here to stay.
While some people believe we're opening an unprecedented amount of opportunities, others are deeply convinced we're unconsciously playing with Pandora's box lid.
As for every technology (from a toothpick to nuclear energy) the truth is in-between and we can't see it as black or white.


We can't refuse the aid AI will give to our poor brains, which are more and more overwhelmed by an amount of information our biology is yet to be able to manage. Helping us understand what to focus on by automating trivial tasks will be mandatory in the future. 

On the other side, you may want not to delegate relevant decisions to something else if you don't have all the pieces of information at hand. If you don't own the whole process, you don't know if that will be a trivial task or not at all.

So there is of course a given amount of trouble we have to face, even us tech enthusiasts. 

Governments are well aware of the situation and they already see an opportunity to protect their citizens and at the same time create barriers to entry into the market for foreign players. Leading the AI revolution is the new mantra for the most advanced countries and regions that want to play a role in the future economy.

Therefore, brace yourselves, regulations are coming. 

The EU, US, Brazil, Canada, China, and many more released or are going to release new regulations.  "OK," - you may say - "we survived HIPAA, GDPR, and so on, we'll survive this one as well!". That's true, we have to. Businesses will have to, and those that will adapt quickly will get a market advantage as buyers - especially in highly regulated sectors like healthcare - will never take the risk of not checking all the boxes. 

However, this comes at a cost, for companies, and for citizens.

I lead a 10 people company only, but we've already got information security (ISO 27001) and quality (ISO 9001) certifications, and being EU based, of course, GDPR compliance. 
The next move will probably be the Medical Device Regulation. But if you go to The Netherlands, you also need compliance with the NEN 7510, which is a 27001 with more controls. Or with the Patient Data Protection Act in Germany. Or HIPAA in the U.S...which differs from U.S.'s HITRUST, which differs from 27001. 

You've got the point. The cost of achieving and maintaining compliance must be seriously taken into account and monitored.

Then we have the cost for people, a bit more hidden. We're on a global market, requiring entrepreneurs a global mindset, but with local to regional regulations and a resulting budget that is shifted more and more to making the products compliant rather than innovative, as the company grows. And guess what? larger companies are typically considered scarcely innovative by end users - anyone here with hospitals with systems running on Windows7? Trust me, they exist.

As solutions are not easy, we can only welcome the effort from vendors like IBM to provide compliance as a commodity, as a part of the underlying infrastructure, and hope that regulations bodies out there will try to increase compliance among themselves, and will provide a legal framework to recognize the regulatory effort already undertaken by a company elsewhere.

Ivan Porro

CEO at SurgiQ