Regulatory Landscape: Understanding Requirements in Custom EHR Development

As healthcare professionals, we both know the growing dependency of healthcare practices of electronic health records and for good reasons. The EHR systems have not only facilitated quality patient care activities but also made it simple for administrators in seamless data management.

However, a generic EHR system hardly meets the unique needs of specialty healthcare practices. This has given rise to customized EHR software development, due to which healthcare practices were able to meet their specific workflows and functionalities.

Furthermore, given the sensitive nature of data that these EHR software deals with, patient data privacy and safeguarding of that data is extremely necessary. And since the healthcare industry is prone to cyber attacks, the government has laid down a legal framework to ensure patient privacy, data security and system interoperability.

On that note, let’s navigate the legal, regulatory landscape for EHR software development. Let this blog be your guide to ensuring compliance with regulatory requirements.

Understanding Key Regulatory Frameworks

Some of the key regulatory frameworks that you need to understand and adhere to are given below:

1. HIPAA (Health Insurance Portability and Accountability Act): HIPAA compliance in EHR software development is a major milestone that you need to achieve. Being a federal law, it not only regulates the legal landscape for the protection of health data but also in its ethical use. That is why it is necessary for healthcare organizations to adhere to HIPAA to ensure patient privacy. Furthermore, failing to comply with HIPAA can lead to hefty fines and even reputation damage.

2. HITECT Act (Health Information Technology for Economic and Clinical Health Act): HITECH compliance in EHR development is similar to HIPAA, but this one majorly focuses on data security measures and meaningful use of the EHR system. However, the major aim of this act is to promote the use of healthcare IT systems and to get the desired healthcare outcomes.

3. Meaningful Use Criteria: The patient health information that your EHR system will collect can be used in many different ways. To ensure that it is only used for care delivery, the meaningful use criteria establishes specific functionalities and data exchange requirements your custom EHR needs to meet to meet the quality of incentive programs started by the government.

4. FDA (Food and Drug Administration): For remote monitoring of patient health vitals, you will have to rely on certain devices. To ensure that those devices are safe to use and FDA approval is needed.

Interoperability Standards

Now that we’ve covered most of the legal requirements for EHR software development, let’s have a look at the interoperability standards that you need to adhere to for seamless flow of data from one healthcare system to another.

1. Compliance with FHIR (Fast Healthcare Interoperability Resources)

FHIR standards are nothing but a set of standards that allows desperate healthcare systems to seamlessly exchange data between healthcare information systems. HL7 FHIR acts as a common ground for the healthcare system to communicate with each other in an understandable manner and seamlessly share information.

By complying with HL7 and FHIR, you can securely and seamlessly exchange patient data with various healthcare providers and care team members to deliver timely care.

However, the compliance frameworks might change depending on the region you’re practicing in. Here, it becomes necessary to identify those national and international interoperability guidelines to ensure that the data is shared in a safe environment and does not land you or your practice in legal trouble. For instance, if you’re practicing in European Union countries, then GDPR compliance in EHR development is necessary, along with other necessary interoperability.

Patient Consent & Authorization

For virtual care delivery, you first need to attain patient consent from the patient as a green signal from the patient to allow you to use their data and deliver care. And obtaining patient consent is easier said than done. While there are several ways that you can use to get their patient consent, digital patient consent or physical consent are some of the best ways to get it.

Furthermore, for your virtual care delivery program, you need to implement a functional mechanism for obtaining patient consent. Draft a clear patient consent form for data collection, storage, and sharing of patient health data within the custom EHR system for delivering care.

For this also you need to comply with the legal requirements for patient data sharing, one of the best examples of this can be the HIPAA authorization forms, which provides you with all the necessary guidelines that you need to adhere to for sharing patient data.

Last but not least, make your custom EHR software a one-stop solution for healthcare delivery, where you can incorporate features within your system to effectively manage patient consent and authorization processes. Clearly outline the process of getting consent and align your software in that way to ensure you get patient consent before starting to collect their data and deliver care.

Building a Secure & Compliant EHR System

The sensitive nature of patient data that your EHR system deals with and the healthcare industry being prone to cyberattacks make it necessary for you to build a secure and compliant EHR system. Here are some of the compliance strategies for EMR software development that you can use for building a secure EHR system:

1. Data Security Best Practices: Data encryption best practices in healthcare IT are used widely for protecting sensitive patient data. Furthermore, role-based access controls for restricting unauthorized access and audit trails for tracking system activity are some of the best practices that you can use to ensure that your data is secure.

2. Implementing User Authentication and Authorization Protocols: Implement robust user authentication mechanisms like passwords or multi-factor authentication and authorization protocols to define the roles of users who can access patient data and who require permission from the admin to access that data from the EHR system.

3. Ensuring Data Integrity and System Validation: Maintaining data integrity is crucial for care delivery and also reimbursement. By implementing a data validation process, you can not only improve the accuracy of the data that is being shared but also ensure the completeness of patient data within the EHR.

4. Maintaining Compliance with Ongoing Regulatory Updates: The healthcare landscape is changing with technology and that is changing the regulatory landscape as well. That is why you need to stay updated with the new regulations and implement the necessary changes every now and then within your custom EHR system to ensure your system is always compliant and in adherence with the regulatory landscape.

Partnering with the Right Experts

To adhere with the legal requirements for EHR software development you need to partner with experienced custom EHR developers. Since they already have experience in developing robust custom EHR systems, their deep understanding of the healthcare regulations and data security best practices, speeds up the process for you.

Furthermore, you can collaborate with legal and compliance professionals to ensure that your custom EHR software system is in adherence to all the relevant regulations. Though it is hardly a common practice, utilizing it can help you build a secure and compliant EHR system, saving a lot of time and potentially causing trouble for your custom EHR development.

Last but not least, leverage industry-specific resources and guidelines provided by healthcare organizations and regulatory bodies. Your custom EHR system is not only safe and secure but also interoperable and an integral part of the healthcare landscape.

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