A Road Paved with Good Intentions

The 21st Century Cures Act and Patient Access to Personal Health Information

© Photo by Dani Bregman

In 2016, Congress passed the 21st Century Cures Act, a multiphase, multidomain, multibillion-dollar piece of legislation meant to harness and utilize our vast national research and data-collecting capabilities for the public good. Most of the money went to the NIH, to fund things like Precision Medicine, Brain Research, Regenerative Medicine, and something called the Beau Biden Cancer Moonshot. 

So far so good I guess, although as a primary care doctor, I would have liked to see a few bucks thrown toward making it cheaper and easier for the average American on planet Earth to get basic medical care before shooting for the moon - but why quibble? I can think of plenty worse ways to spend our tax dollars.

The Cures Act also mandates the free exchange of health information, which means that healthcare providers must give patients access to their medical records - including notes and test results - without delay. This idea - providing instant access to office notes and test results, regardless of whether the doctor has reviewed them - has important implications, some good, some bad, and some ugly. 

First, the good, which is pretty self-evident: of course patients should be able to see their health information. The idea of having the right to your medical records is well established, although in the past you often had to jump through formidable and frustrating administrative hoops. 

With the Cures Act, the process of obtaining one’s records should be easier, which is a good thing, although there are still exceptions. Correctional institutions can deny access to medical records, as can Psychotherapists. In fact, any provider can deny access to information if they determine that seeing it will have adverse or detrimental consequences for the patient. But in general, society has come to a broad consensus that - whether in the real world or online - individuals own their data.

Next, the bad: most patients don’t understand raw medical data like labs and radiology reports. Why should they? First, the language is technical. Second, just because a result is marked as “abnormal” doesn’t make it significant. Third, all findings - whether normal or abnormal, significant or insignificant - must be seen in the proper clinical context.

Take a simple cholesterol result of 230. Sounds high. But what’s the breakdown? Is it mostly bad lipids like LDL, or good lipids like HDL? And is it significant? Cholesterol itself is not a disease. It’s a risk factor for vascular events like heart attack or stroke. Cholesterol is one factor that contributes to overall risk but there are many others, and it’s the projected cardiac risk over time that drives the proper treatment.

Furthermore, the clinical context includes medical history, family history, associated test results, and prior test results…. I could go on, but believe me when I say that this example is the least of it. The bottom line is, just because a number on a report is shaded in yellow doesn’t mean it’s time to put your affairs in order. 

Finally, the ugly.

A few weeks ago, a patient told me a story. Over Spring Break, she went to Jamaica for a long-awaited family vacation, the first since Covid. She and her husband had rented a big villa at a beach resort, and everyone came - extended family flew in from all around the country. 

On her first day there, my patient received an email. She had been having some pain and her doctor ordered a CT scan, which had been done the day before she left. As per the new federal regulations, the radiology center sent her the report as soon as it was dictated. One item stood out: multiple masses in the liver, clinical correlation suggested.

Wait, what? Masses in the liver? Don’t quite like the sound of that! She looked up the phrase on the internet, and that sealed the deal: she had metastatic cancer, most likely originating from the colon. She was going to die. 

She tried to reach her doctor, but he was unavailable. Other attempts at clarification failed. Long story short, that presumed diagnosis hung over the family for the entire week. As you might imagine, it was not the most awesome family vacation ever.

When she got home, she met with her doctor at a follow-up visit. He took one look at the film and said, “Oh, look at that - hepatic hemangiomas. Those are nothing to worry about.” 

Wow, great… I guess?

Lest you think that story is an anomaly, it’s not. I present exhibit B, which occurred around the same time. I was at a party - food, drink, music blasting - when a friend approached me with a look on his face.

“Can I ask you something medical?” he said. “I just want to make sure I got this right.”

We found a (relatively) quiet place. He pulled out his phone and showed me a copy of a biopsy report that had been dumped into his wife’s MyChart app. This time the diagnosis really was a malignancy. 

The results came in on Friday, and now it was the weekend. I wasn’t much help except to confirm what my friend already knew. As for prognosis, treatment, recovery - what the future would hold - I had some idea but I couldn’t really say. Only the doctor could and honestly, I felt bad for him too.

When I was a medical student and all through residency, our attendings spent time and effort teaching us how to deliver bad news. It was considered an important and necessary clinical skill, even somewhat of an art.

Lesson number one was that it be done in person, face to face, not over the phone, and never by text or email. Strangely, I can’t recall anyone specifically stating that a diagnosis should not be delivered directly to the patient, without being filtered or seen by the doctor at all. 

I guess they figured it goes without saying.

Of course, there is always the other side. What about patients who have tests done and never get results? Most of the time that means that everything’s OK, but don’t they deserve to be told? And what if it means the specimen was lost or damaged, or even worse, an abnormal result somehow slipped through the cracks and was never actually seen?

The good news is, there’s an obvious fix: a simple lag time. 

Let’s say I order a study and the lag time is a week. That means I have a week to review the findings and respond appropriately.

If the results were critical, the laboratory could reach out to me urgently, as is currently the case. If they were abnormal enough to merit discussion, I could schedule a follow-up or reach out directly. If I planned to be away, I could arrange for coverage, log in remotely, or change the lag time with the patient’s consent. 

When the lag time elapsed, results would automatically go to the patient, providing not only timely access but a fail-safe guarantee: no word would not imply that everything is fine.

So, if anyone has connections in Congress or with the Biden administration, go ahead and pitch the lag. You can gladly take the credit. The increased peace of mind would be reward enough for me.