Health Interoperability
8 Min Read

Discussing KHZG, ISiK and the 21st Century Cures Act over Dinner at DMEA 2022

Rien Wertheim

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Discussing interoperability and cultural differences between Europe and the USA

Last week, we were at DMEA in Berlin, our first in-person event in Europe since COVID-19 hit us. DMEA is a large Europe / DACH focused event in digital healthcare. It’s the closest thing (in size) to the annual HIMSS US conference that we have in Europe.

I noticed that KHZG won the popularity contest at DMEA in booth ads. I counted the word KHZG on dozens of back walls, banners, brochures and TV screens.

This triggered an interesting discussion during dinner after one of our DMEA days. A discussion about different rules and regulations that governments install to drive health interoperability. But before we dive into our table talk, let’s take a closer look at KHZG and ISiK.

What is KHZG?

KHZG is the Hospital Future Act, a federal and state funding program of €4.3 billion with the goal of propelling German hospitals into the digital age. KHZG requires uniform data processing standards that have been tested in clinical practice. Interoperability is a key element in KHZG. However, the program is not very specific when it comes to which standards to use. KHZG says (translated freely): “If KBV (for outpatient use cases) or gematik (for inpatient use cases) have defined interfaces for clinical models, use these. If not, use international, accepted standards, like IHE and FHIR.”

What is ISiK?

Another federal law is ISiK (Informationstechnische Systeme in Krankenhäusern), which aims to decrease fragmentation of the hospital IT landscape by mandating interoperability. ISiK is very specific on standards and deadlines: hospitals need to have ISiK-compliant FHIR interfaces in place by June 2023. ISiK has one flaw: there are no fines involved when not meeting the requirements or deadlines (at least, to my knowledge).

Discussing health interoperability during dinner

On Tuesday, after a long first day at the Messe Berlin, Simone Heckmann from Gefyra, James Agnew from Smile CDR, and Alexander Zautke, Yannick Börner and myself from the Firely team went out for dinner at a place called Koshary Lux, an informal Moroccan restaurant on Grolmanstraße, near Kurfürstendam. (We were lucky to have Yannick in our team, who lives in Berlin and knows his way around).

Left to right: James Agnew (CTO at SmileCDR), Alexander Zautke (FHIR Software Engineer at Firely), Simone Heckmann (CEO at Gefyra), Yannick Börner (Software Engineer at Firely).

Despite the informal context, we couldn’t help ourselves from discussing what we like most: health interoperability. Simone brought up an interesting point that kept us talking all evening. To what extent should governments be specific about standards? And what can explain the differences between for example Germany and the US?

The government’s role

It is obvious that interoperability is beneficial for society at large. That is why governments around the world are stimulating (to say the least) interoperability to improve healthcare and save money. In fact, the adoption of FHIR is currently mainly driven by governments’ efforts.

Not being clear about standards certainly does not help in achieving a seamless flow of information. But how specific can the government be when issuing a law or funding program? You could argue that the rule should just give some minimal guarantees to achieve a certain desired goal (interoperability). But if these minimal requirements fall short, then what? Prescribe the standard, the version of the standard, the underlying data model of the EHR? This can go on and on, to the point of absurdity, e.g. mandating the database or EMR brand.

What should governments do? What is the right balance in enabling and mandating interoperability? Let’s take a look at the 21st Century Cures Act (21CC) in the USA.

What is the 21st Century Cures Act? And how does it differ from KHZG and ISiK?

The 21st Century Cures Act (21CC) is a United States law that aims to give patients and their care givers secure and free access to electronic health information (EHI). 21CC requires “health IT developers” to have very specific FHIR interfaces in place before the end of 2022.

There are at least three key differences between ISiK/KHZG on the on the hand, and 21CC on the other hand:

  1. 21CC includes fines for health IT developers in case of violation of the law. These fines can be substantial. ISiK does not include fines.
  2. The 21CC targets the patient, whereas ISiK and KHZG target the hospital.
  3. The 21CC is very specific about the standards it requires: USCDI (United States Core Data for Interoperability) version 1 according to the US FHIR Core implementation Guide for FHIR Release 4.0.1. KHZG is less clear about standards.

These differences sparked our dinner discussion: what could be an explanation of these differences? And why can something be effective in one country and be inappropriate in another?

Cultural differences play an important role when driving health interoperability

Of course, we didn’t find the holy grail for governments during our “DMEA dinner” (despite a few beers).

When it comes to driving interoperability, the government has two instruments: the carrot and the stick. Obviously, KHZG is a huge carrot, similar to VIPP and MedMij in the Netherlands and the FHIR incentive program in Israel. ISiK is more of a stick (with a hard deadline, June 2023). However, you could argue that ISiK is a toothless rule if it doesn’t include fines. 21CC is a stick that can hurt. Why a different approach in Germany? The German situation is characterized by a perpetual balancing act between federal government and the Bundesländer. Germany does not have a federal ONC. A German equivalent of the 21st Century Cures Act would be unthinkable. That’s why a funding program, even as big as KHZG, and a rule without fines, seem more suitable for the German market.

Rules for health interoperability: focus on patients or on hospitals?

In Germany, the “beneficiary” of policies is the hospital, in the US it’s the patient. Why would that be?

Affordable access to healthcare is less obvious in the US than in Germany and other European countries. Taking control of your health and treatment is more a phenomenon in the US, where your health and financial situation may depend on having access to health information. No wonder the US have their ePatient Dave, with his motto Give me my DaM [“data about me”] data. Moreover, Europe is far more wary of data security and privacy (think GDPR), meaning: more legal and security barriers for patient data access.

FHIR adoption – final thoughts

In Europe, most people still believe that the government will take care of you when it comes their health, whereas in the US the general belief is that you have to take care of yourself (‘and give me my data’). Regulations are developed to empower patients. Combine that with strict deadlines and fines, and you will understand why the US is the most mature market in terms of FHIR adoption.

We ended our inspiring dinner conversation with the reverie that, overall, it’s probably better to be a patient in Europe. But if you want to stay ahead of the curve in FHIR, it’s better to be in the US.

Firely is certified for ISiK by gematik. We’re helping our customers in Germany create ISiK and ISiP FHIR interfaces as required by federal regulations. Read all about the tools we offer so you can launch your ISiK solution before June 2023.

Not in Germany? Our 21CC compliant solutions are here. For VIPP and MedMij in the Netherlands, click here.

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