Troy Bannister

Particle Prediction: A Sea Change for Healthcare IT in 2021

November 19, 2020

Biden shared the frustrating yet all-too-familiar tale of the peril when patients can't get seamless access to their own medical records. Troy was struck: how could the second-most powerful man on the planet not have the right resources to help his son?

In January of 2018, I stood at the front of the StartUp Health Festival to hear Joe Biden deliver an unbelievable, sadly all-too-familiar story of how Beau, his now deceased son, couldn’t get medical records from one doctor to another. 

This was, I really think, the initial snowflake that snowballed into what is now Particle Health. I recall standing there, thinking, “How can the second most powerful man on the planet not have the resources to solve something like this?” His story is one I remember to this day and have consistently heard time and time again when we talk about Particle. 

It was the first time I realized that, maybe, health interoperability wasn’t a technology problem so much, but rather an incentive and alignment problem.  

The Trump Administration was, perhaps surprisingly, very progressive with healthcare IT policy.  The Anti-Information Blocking provision under the 21st Century Cures Act passed under Trump - in fact, he was scheduled to speak at HIMSS in March 2020 right before COVID cancelled the event - and TEFCA was pushed along. Then there was price transparency, ADT requirements, USCDI and a host of other items.  

Of course, COVID has thrown everything for a loop. Hospitals have stopped buying services, the Anti-Information Blocking Rules were postponed by an additional six months (I’d wager they would have still without COVID) and the future is somewhat uncertain as a new administration takes over.  All I can say in regards to healthcare IT policy and more specifically, interoperability for sure, is that Biden has an unforgettably painful experience dealing with a health system that couldn’t share data. A health system that, whether it failed or not, left him with unimaginable pain and sorrow.  

Our massive industry is moving toward enabling better patient outcomes by enabling the trusted sharing of data. It’s bipartisan, it’s emotionally charged by the now president-elect and the laws have been passed. Now, the question is how might it play out? 

Well, the way we see it, on April 5th 2021 it will be illegal to block a patient’s requests for their own data... unless the request falls under any of the following exceptions: 

  1. Preventing Harm 45 C.F.R. § 171.201
  2. Security Concerns 45 C.F.R. § 171.202
  3. Privacy Concerns 45 C.F.R. § 171.203
  4. Infeasibility C.F.R. § 171.204
  5. Health IT Performance C.F.R. § 171.205
  6. Content or Manner of Request 45 C.F.R. § 171.301
  7. Fees 45 C.F.R. § 171.302 
  8. Licensing 45 C.F.R. § 171.303 

Particle participates within national exchange frameworks written and enforced by EMRs, the ONC (by way of the Sequoia Project) and other healthcare organizations. Today this data is exchanged under a ‘Treatment’ purpose of use which requires the data to stay between Covered Entities. This somewhat eliminates the need for most of these exceptions ever being problems. The doctor accessing the data from the EMR is obligated to prevent harm, keep the data secure under HIPAA certified systems, legally access all EMR data for care and has no issues with Health IT Performance, content, fees or licensing issues. 

But all this changes when we, instead, are sharing data directly with a patient and not a doctor. Now, with patients at the wheel, there are arguments to be made for some of these exceptions.

Some concerns, like the Infeasibility Exception and more specifically Segmentation, should probably be on the EMR. 42 C.F.R. Pt.2 sensitive information like mental health, substance abuse and sexual disease history data should never make its way back to the patient directly, without provider mediation (a la 23andMe). The EMRs responding to requests are able to remove this data, should a patient request it. 

Other concerns, like the Privacy Exception, can be handled by multiple stakeholders. When sending an EMR a request for data on behalf of a consumer, how can we be sure we’re bringing back the right record and not someone else’s with the same or similar name by mistake? The requesting platforms, who are pulling the data on behalf of a patient (like a Personal Health Record, for example), should be responsible for confirming the identity of the individual, but can’t possibly match that identity to the correct record within the EMR.  That must fall on the EMR.  

Most of these exceptions are figured out. We’re doing these document exchanges today at scale. But what exceptions might we get hung up on, even after the rule is enforced? For that we’ll have to wait and see.  

The good news? We have a ton of momentum from the past administration and a whole lot more coming from the new one. We know the intent behind the new rules and Particle is incredibly focused on embodying the spirit of the laws, moving at a steady pace toward making them a reality in the near-term. It will be interesting to see what exceptions are claimed and how the industry works together to figure them out.  


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