What happens when a patient writes the rules

Imagine spending eight years fighting a healthcare system for your own diagnosis. Now imagine someone hands you the pen that writes that system’s rules. What would you change first?

Regulation feels like the least human part of healthcare. Rules arrive as acronyms, deadlines, and compliance checklists, and it is easy to assume they were written by people who have never sat in a waiting room. Sometimes that is true. But rules exist because fragmentation does not fix itself. Left alone, systems stay disconnected and patients keep paying the price. And behind some of the most consequential rules in healthcare are people who lived the failure they are trying to fix.

This is the second part of a story I have been telling about one of those people. In the first part, Denise St. Clair spent eight years undiagnosed while the evidence sat in record systems that could not talk to each other, until she compiled her own paper chart and a cardiologist finally saw the whole picture. If you have not read it, start there.

This part is about what she did next. Because what she did next changed US healthcare.

“What can you do?”

Denise was never supposed to work in healthcare. She has a master’s degree in African studies and was headed for the United Nations. International policy was the plan. Between degrees, she went to a temp agency to find some work. They asked what she could do. Her answer, in her own telling: “I can’t do anything. I don’t know. Research, I guess.” They placed her at a research firm that did federal contracting work, and she ended up in its education division while she started her PhD.

Then came the eight years, the wheelchair, the paper chart, the tumor, and the surgery. And then came a conversation that decided everything. Denise went to the firm’s vice president and asked a question: “We have a healthcare division, don’t we? We have some things to fix there.”

That was the pivot. Not a mission statement, not a career plan. A patient who had seen exactly where the system breaks, deciding to go and work on it from the inside.

The inside of the machine

Denise worked her way through federal healthcare contracts, supporting government agencies from the outside. Eventually she concluded that if she really wanted to move things, she needed to be inside. So she joined the Centers for Medicare and Medicaid Services, better known as CMS: the agency that runs Medicare and Medicaid, and one of the most powerful levers in American healthcare. For readers outside the US, think of it as roughly the equivalent of a national health authority setting the rules for a very large share of the population.

Not long after she started in the office of legislation, an old friend called her boss and asked for her by name. They were about to start writing a regulation, and they needed help. That regulation became the interoperability and patient access rule: the first regulation in the United States to require FHIR, the open standard that gives health systems a common language for exchanging data. Its goal was simple to say and radical in practice: patients get electronic access to their own health data. The right data, in the right place, at the right time.

Think about who was writing it. The person helping write the rule that gives patients access to their records was the same person who had spent years collecting wet signatures, one practice at a time, to assemble her own chart by hand.

“If there was anything I was passionate about, it was getting the right data at the right place at the right time. So I got very lucky to be able to do the thing that mattered most to me.”

She did not stop there. Her next assignment was the rule that became the interoperability and prior authorization rule, known today as CMS-0057-F. Keep that name in mind. In the next part of this story, that rule stops being policy and becomes personal, in a way even Denise could not have scripted.

Why this matters beyond Washington 

It would be easy to file this under American politics and move on, especially if you work in healthcare somewhere else. I would push back on that, for two reasons.

First, rules written by people who lived the problem aim at different targets. Patient access was not an abstract principle to Denise. She had lived what its absence costs: the years no one could bring her records together to see the whole picture, and the health complications because of that. That is the difference between regulation as paperwork and regulation as repair, and it shows in what the rules actually require.

Second, the question those US rules answer is now being asked everywhere. The European Health Data Space is built on the same premise: patients should have access to their data, and data should follow the patient. Germany is mandating standardized interfaces in its hospitals. The direction of travel is global. What differs between countries is the pace, and the pace is a choice.

The pen that writes the rules is in more hands than you might think. Some of those hands have pushed a wheelchair.

The pen is in more hands than you think

The rules Denise helped write mean that in the US, patients now have a legal right to electronic access to their health data, delivered through FHIR, an open standard that gives health systems a common language for exchanging data.

If you are a patient, that right is real, and you are allowed to use it: to ask for your records, and to expect them to follow you. If you work in healthcare, in policy, or anywhere near these decisions, Denise is proof that the person who fixes this does not have to be someone else. Waiting for a mandate is itself a choice, and the pace of change is set by people who decide not to wait. A rule on paper is not the same as a rule working in your own case, though.

The next part of Denise’s story is about the day she found out, as a patient, whether the system she helped design actually worked.

Watch our full conversation about what happens when interoperability fails.