FDA wants to regular off-label use of ML-driven devices

Obtaining FDA approval can be a difficult and long process. “The traditional paradigm of medical device regulation was not designed for adaptive AI or ML technologies, which have the potential to adapt and optimize device performance in real – time to continuously improve healthcare for patients,” the report said.

“The highly iterative, autonomous, and adaptive nature of these tools requires a new, total product lifecycle (TPLC) regulatory approach that facilitates a rapid cycle of product improvement and allows these devices to continually improve while providing effective safeguards.”

For example:

If a manufacturer decides that its device that studies retinal scans for diabetic retinopathy can also measure if a patient has high blood pressure or not, it’ll have to contact FDA officials to check if the device can be used for that purpose.

Meanwhile, we can’t even figure out how to figure out the ethics of AI.

This is probably a good space for that Talebian thinking that goes “start with what’s worked for thousands of years, and probably don’t stop.”

Source: Not so fast AI Doctor, the FDA would like to check how good you really are at healthcare

Link: DOJ approves $69B CVS-Aetna merger as healthcare industry restructures

CVS, which racked up about $185 billion in revenue last year, runs the country’s largest retail-pharmacy chain and provides prescription plans to more than 94 million customers. By joining forces with Aetna—the nation’s third-largest health-insurance provider with over 22 million medical members, earning $60 billion in revenue in 2017—CVS will have a tight grasp on the market. The combined enterprise aims to be a first-line health care hub with clinics in its ubiquitous brick-and-mortar stores.
Original source: DOJ approves $69B CVS-Aetna merger as healthcare industry restructures

Link: The Bezos-Buffett-Dimon health care venture: Eliminate the middlemen

“There’s ample room to replicate that success in health care, because the system in the U.S. has long been plagued by excessive transaction costs – the expenses incurred when buying or selling goods and services. These include irrational pricing, as evidenced by the price of services varying wildly for hospitals, insurers and patients. This, along with unnecessarily complicated billing systems, creates the need for extensive bureaucracies to manage all the varied relationships.”
Original source: The Bezos-Buffett-Dimon health care venture: Eliminate the middlemen

Link: Warren Buffett reveals more details about healthcare venture with JPMorgan and Amazon

“We have got a huge, competitive disadvantage in American businesses, far more important than any tax change, in terms of our healthcare costs.”
Original source: Warren Buffett reveals more details about healthcare venture with JPMorgan and Amazon