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It’s not easy to be compliant in healthcare. Especially if you are a healthcare application development provider accountable for secure data processing and storage.
You must follow a range of stringent regulations and healthcare data security standards, including HIPAA, FHIR, and others. Otherwise, a healthcare organization that will adopt your software may be penalized.
Those who fail to meet data standards in healthcare may be fined up to $50,000 US dollars per civil violation. For a more serious offense, like selling PHI data, an offender may get a 10-year jail sentence.
An Illinois-based healthcare network is famous for the largest HIPAA settlement that resulted in a $5.5 million penalty. Because of insufficient risk analysis, the data of four million people was compromised. A dear price for the lack of physical and administrative safeguards, isn’t it?
To save your nerves and reputation, Leobit’s team has prepared an overview of top healthcare regulations and compliance rules. Let’s talk about building HIPAA compliant software, HL7 standard, and other data standards in healthcare:
HIPAA stands for Health Insurance Portability and Accountability Act. It is a US legislation signed on August 21, 1996, to implement data security provisions that protect patients’ medical information. HIPAA regulates the processing of protected health information (PHI) by any organization working on the US market.
Therefore, when healthcare application development providers design solutions that require medical data processing, they have to follow HIPAA. Only HIPAA compliant software will allow their customers to observe the law.
For example, if an application has an electronic-health management feature and enables clinicians to track patients’ progress, it must be compliant. This solution will store confidential information of different individuals linked to their treatment history.
Hence, before racking your brains about reaching HIPAA compliance, clarify whether you need it. First, analyze what kinds of data you will process. Second, think about who will use this tool and what for.
You can read about the best practices in healthcare application development in our previous article.
If you create software for one of the HIPAA covered entities and/or deal with protected health information, mind HIPAA software requirements. Let’s discuss the key provisions of the HIPAA Security Rule below.
Fortunately, the creators of HIPAA clarified every aspect of the compliance. The HIPAA Security Rule lists all the technical, physical, and administrative safeguards that must be implemented. If you have them in place, you can sleep peacefully without worrying about HIPAA compliance.
Note you can choose any means to provide these safeguards.
Technical safeguards are something you as a software developer should focus on. Without them, a healthcare organization that will later use your application won’t be able to comply.
|Safeguard||How to implement|
|Access controls||An engineering team must implement procedures that allow only authorized users to access PHI. For example, you can use a password, PIN code, token, key, or biometric data, such as fingerprints and voice|
|Audit controls and activity logs||To track what’s happening with PHI, a compliance app must log all actions. Thus, it’s important to implement hardware, software, and/or procedural mechanisms that record activities in the system and audit them|
|Integrity controls||HIPAA healthcare regulations and compliance require software providers to use procedures that protect data from damage or changes. It’s necessary to identify all authorized and unauthorized access attempts and develop the integrity policy|
|Data transmission security||Healthcare software must support technical security measures that prevent unauthorized access while PHI data is transmitted|
These safeguards are related to physical access to ePHI, such as a place of storage, workstation, and smartphone security. They must be implemented jointly by the tech team working on the healthcare solution and the organization that uses the app.
|Safeguard||How to implement|
|Facility access control||Only authorized people should have physical access to the facilities of a covered entity|
|Workstation and device security||A covered entity must restrict the use of workstations and mobile software that have access to PHI. Video surveillance, door and window locks, security system, and data deletion from mobile devices after employees leave the facility are the most popular ways to do this|
These safeguards dictate healthcare organizations that use HIPAA compliant software how to manage it. Overall, they need to assign a security officer, analyze risks and limit access.
|Safeguard||How to implement|
|Information access management||Covered entities should ensure “minimum necessary” use and disclosure of PHI. The staff will access PHI only when it needs this data to provide services. Therefore, a healthcare application development team that works on the software has to build it with flexible access controls|
|Risk analysis||For HIPAA compliance, it’s necessary to identify how PHI is processed and analyze potential risks. A healthcare software development team provides a software owner with a clear understanding of data usage practices|
|Security personnel and training||After the software is launched, covered entities must designate a security official and regularly train their staff on how to recognize a cyber attack|
|Data security assessment||A covered entity must perform periodic security checks. This is necessary to make sure the security level meets HIPAA software requirements|
As a healthcare software development provider, you are mainly responsible for the technical part of HIPAA compliant software development. But you can help the covered entities with other aspects. Physical and administrative safeguards depend on technology and HIPAA compliance software vendors. If a software solution processes medical data securely, it will be easier to implement other safeguards.
In the US, around 1500 million data breaches happen annually. Out of this number, a large share of attacks target healthcare data. According to HIPAA Journal, in 2020, from 400 thousand to over 9,7 million healthcare records were compromised every month.
Even though HIPAA healthcare regulations and compliance help to protect software from intervention, also follow healthcare data security standards. FHIR and HL7 are the key standards to remember during healthcare software development.
HL7 (Health Level Seven) is a set of international standards established to control electronic medical data management, exchange, and integration. They determine how to transfer clinical data between software applications used by healthcare organizations.
Fast Healthcare Interoperability Resources (FHIR) standard appeared as an alternative to existing HL7 interfaces standards. But developers and end-users faced operational difficulties caused by the use of HL7v3. Since the HL7 standard was complicated to work with, it was necessary to create something with the same functionality but simpler. That’s how the HL7 FHIR standard was born.
The FHIR standard has better interoperability than the previous versions of HL7, the healthcare standard. In FHIR software, all resources have a common set of metadata, definition, representation method, and a readable part. The system must be securely interpreted by any other software and read by any device type.
As the transition to FHIR has only started, currently, both FHIR and HL7 software standards are used in healthcare software development.
HL7 healthcare standards, including FHIR, enable healthcare service providers to maximize the benefits of modern technology. To understand in what way, let’s imagine a situation.
When a physician diagnoses a patient and assigns treatment, the doctor needs to access multiple electronic systems. If the services don’t follow the same interoperability FHIR and HL7 software standards, the risk of mistakes is high. The physician may fail to receive the necessary data and misinterpret the information because of missing standardization.
Healthcare regulations and compliance with HL7 interface standards allow software providers to integrate solutions. This optimizes the work of physicians and enhances the quality of care.
Therefore, FHIR and HL7 software standards act as a bridge between modern healthcare services and advancing information technology.
HIPAA and HL7 healthcare requirements are the main healthcare regulations and compliance standards to follow. But your healthcare application can also become more secure and interoperable if you use other measures.
Here is an overview of other critical standards.
The need to meet these standards depends on the functionality of your app. Therefore, before you implement any new feature, learn the related standards and take care of compliance.
Starting work on an EHR, telehealth solution, healthcare compliance software, or any other compliance apps, you must know the rules.
Otherwise, you will need to assemble a team with the relevant experience or hire a software development vendor. Whereas in-house recruitment takes a lot of time, outsourcing enables you to initiate HIPAA compliant software development as soon as you find the right company.
Leobit is an outsourcing company skilled in developing compliant healthcare software. Since we have completed multiple healthcare projects for customers from the US and Europe, e.g., the app for booking hospital appointments, we know what regulations affect different markets.
Contact Leobit to discuss your healthcare development needs.