How to Comply with the Latest US Legislation on Patient Data

By  //  November 23, 2021

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The US Cures Act review 

In July 2021, the new healthcare legislation regulating patient data issues will come into force in the US. The changes will affect not only hospitals and private clinics but also insurance firms and healthcare software development companies. What to expect from the innovations? What measures should firms take even now?

Fast facts

The 21st Century Cures Act is new healthcare legislation that regulates the handling of patient data. This is an update to the current US law that was originally released in March 2020. However, given the circumstances related to the coronavirus infection spread, it was decided to postpone the enforcement of the updated legislation until July 2021.

The above document is the finalized set of rules and regulations concerning health information in the US. The law was issued by the US Office of the National Coordinator for Health Information Technology (ONC) and will be in effect in most states.

The backstory 

All types of medical institutions (public hospitals, private clinics, medical centers) collect various patient data in the course of their work. Initially, doctors wrote this information in paper medical records and stored them in a filing cabinet. Over the past fifty years, in the US there has been a transition to electronic data recording.

Now, hard-copy document flow is no longer in place, and electronic files’ storage has undergone many changes. This area is being continuously improved. There are different approaches to handling patient data; institutions use various programs depending on their tasks, specificity, and budget. Such a multi-vector approach has resulted in a need to find a common denominator. It is for this purpose that an update to the patient data law was issued.

What changes the legislation update will bring

The acts mentioned above bring changes that can be considered from several perspectives: patients, healthcare facilities and doctors, insurance firms financing the treatment, and healthcare software development companies.

Patients 

The new legislation puts the main emphasis on the fact that patients will be able to control their medical data and access it quickly and easily. Also, the privacy of all the information will be guaranteed.

It is also about improving the compatibility of data from different sources and providing patients with end-to-end access to it. For example, an American resident is treated in a certain healthcare facility but has to go to another clinic while on vacation. It is important that both the person and the doctor have access to their medical data and can make changes in it. At the same time, such a system is based on simplicity and free operation.

Thus, the Cures Act aims to improve processes, technologies, and standards for creating and sharing health information so that patients can make decisions about their treatment.

Healthcare facilities and doctors

People often go to healthcare facilities when they are in their most vulnerable state. They trust doctors with their health, hoping to receive prompt and professional help.

Hospitals, in turn, do not always have sufficient information about patient history. They often have to waste time on inquiries to other health facilities. Also, doctors have to conduct additional checks and wait for the results to find out details. And yet, there are situations when every minute counts during the treatment process.

Medical data exchange will allow clinics to quickly access a patient’s complete case history, regardless of the system where this information is entered. In addition, the new analysis results, interventions, and symptoms are entered into a patient’s record in real time, complementing their health picture. Thus, medical professionals will save time and effort when working with patient data.

Insurance firms 

Sometimes it takes a long time to figure out the details affecting an insurance claim. Organizations paying for treatment need to have enough information to do everything right when making a payment.

End-to-end access to patient data from all medical institutions will facilitate the process of collecting the information necessary for the proper registration of an insurance claim. This will ensure prompt consideration of the case and help quickly and correctly carry out the insurance payment.

Technical solutions for new challenges 

The aim of the Cures Act is to provide patients with control over their health information. Ultimately, this will improve the quality and effectiveness of treatment. The new data exchange standard was drafted to ensure its interoperability: now, medical organizations can freely exchange information.

For this purpose, a dedicated Trusted Exchange Framework and Common Agreement (TEFCA) was developed. It allows for electronic data exchange from different systems. The framework architecture is a structure with the ability to use multiple access points. This means that different institutions will be able to access the records simultaneously, regardless of what medical data recording system they have installed.

What changes will custom healthcare software development companies face with the introduction of the above legislation?

On the one hand, there will be a need for new applications for patients to access their medical data. Such programs should be as simple and understandable for the average user as possible. Thus, patients will be able to objectively evaluate the information and have a complete understanding of their treatment’s specifics and likely cost. Companies providing healthcare software development services should take this into account.

On the other hand, programs for working with data, which are currently used in clinics, will soon require further development and optimization for the new framework. Now, healthcare facilities are undergoing the stage of evaluating existing software, and vendors are developing new opportunities to improve it.

Preparation plan for the introduction of new legislation

In order to switch to a new way of working with patient data, healthcare institutions are recommended to take the following steps:

Identify data and ensure its quality.

Various institutions use systems with different approaches to recording and structuring medical information. Some of them store structured data where elements are arranged according to a well-defined model. Others enter information into unstructured free form fields. Even within a single hospital, there are often several systems with different approaches.

Therefore, medical software developers should now take the time to identify all the tools, systems, and applications that contain key data elements. This is necessary for the transition to a new work format.

Once the source of information is identified, the gaps are documented and filled. Data quality is crucial to easily switch to an integrated storage model and create a full-scale working base.

Organize data.

Once the data source has been identified and classified as relevant, it is worth moving on to the stage of organizing the data. The Health Information Exchange is in effect for this process. It predetermines what the information exchange procedure should be like and how it should be carried out. Formats, required fields for filling, sources – all this is described in the Standard.  

Prepare to interact with TEFCA.

The software installed in healthcare facilities must comply with the requirements of the new framework (TEFCA). This means that existing programs and systems will require updating and, possibly, developing some missing parts. At the same time, healthcare companies need to analyze their capabilities and ability to adapt to new requirements.

Here, answering the following questions will help them:

How to manage information requests from third parties?

How to securely receive data from third-party institutions and include them in our operations?

How do patient identification management processes work? Are they effective enough?

How to ensure the data have not been changed or deformed when merging from different sources?

How to leverage the opportunities of the new framework to improve the quality of patient care?

How to make sure that all of the rules are followed?

If healthcare facilities find it difficult to answer these questions, then their software requires improvement. 

Build a strategy for a transition to the new working methods.

After evaluating and refining existing processes and technological systems, it is necessary to develop a documented strategy for a transition to the new framework. The strategy should take into account the results of all the evaluations. Basically, it is a roadmap with specific milestones, steps, and required resources.

Conclusions

The new legislation is a significant step towards improving the availability and quality of treatment. The increased ability of patients to manage their health information and the introduction of data exchange standards will give a new impetus to the development of science – as from now on, scientists will be able to analyze a larger amount of information.

Adaptation to the new regulations will definitely require some preparation from healthcare institutions. Healthcare software development is already helping them with that.

These companies create solutions for patients to access their health records and solutions to exchange and process the increased amount of available information. Let’s hope that all these measures will benefit patients and increase their satisfaction with the services provided.