The argument maybe defused. Quacksalvers?

Ok,

So what happened in the DTC market was a fractionating of services with different "legal" arguments for what they were doing in attempts to avoid regulations which comes with all sorts of health care practice.

At that time I argued that these firms WERE DOING healthcare and should be regulated as such.

Astute legal times from Navigenics and 23andME said.....we aren't doing medicine. We are only using algorithms to process results of biospecimens .....Despite receiving cease and desists

They even said, we don't NEED CLIA because we aren't doing clinical testing.......

Yes, in hindsight these arguments did seem silly......they seemed silly to me at the time as well. But then these businesses fell in line, sort of..... Paired with CLIA labs and then we all moved on. But what they didn't do is submit their algorithms to regulation as well. We now see this problem getting larger. Especially as Muin Khoury and the CDC argue for complete transparency of what these "algorithms" are.

Why? Because the CDC, like me feels that they are providing some sort of healthcare service. One that will likely exist in the future as well. So much so that it needs to be regulated now, to prevent all sorts of shenanigans like those that existed even in 20th century healthcare.....

Cocaine for headaches and depression?

Traveling medical shows where women all sat in a train car and......

Mercury to sure mania? We saw that all of these things were used without regulation or guidance, exposing people to significant harm.....

Like the financial industry, the argument that regulations will prevent us from being the world leader in genomic technology is pure B.S. Just like it was with Finance

In fact, I do remember all of these money making brokers saying the exact same things I hear now from Genomicists mouths......

Scary, if you ask me.

So what about these "algorithms"?

Well, a few people confirmed that in California we have some new drafted legislation which could affect all players in this DTC and lab space.....

• This bill would require an entity that provides post-CLIA bioinformatics services, as defined, to contract with a licensed clinical laboratory to process biological specimen collection kits, except as specified.


• The bill would require an entity that provides post-CLIA bioinformatics services to employ a specified expert for approval of the algorithms used in the interpretation of the biological data of a customer.


• The bill would further impose on an entity that provides post-CLIA bioinformatics services specified privacy, recordkeeping, disclosure, and audit requirements, and would impose specified duties on the State Department of Public Health in that regard.


• The bill would also subject those entities to specified provisions of existing law prohibiting unearned rebates, refunds, and discounts, a violation of which constitutes a crime.


• Because the bill would expand the scope of a crime, the bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.


• This bill would provide that no reimbursement is required by this act
  for a specified reason.

We will see if this bill passes. But if it does, it may mean the end of Auctioning Off Genome Scans......

Which puts this technology right in line with the rest of healthcare, where it is ILLEGAL/Ethical Violation to discount, rebate, guarantee or refund.

The Sherpa Says: In my mind, this argument seems to be: "You are healthcare or you are Novelty. You cannot chose both" If this law passes it would be in line with the government of California as well as New York......