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Security and Compliance Importance in Healthcare Software Development

Security and compliance are not mere checkboxes in healthcare software development; they are the cornerstones. Neglecting these aspects puts a healthcare organization at risk of data breaches, undermining patients’ trust, and causing legal issues.

In this article, we’ll take a deep look at what does compliance mean in healthcare, why it’s important, how to make your software compliant, what software for healthcare requires data security, and what types of protected health information are at risk.

If you need to build software for your clinic but aren’t sure which aspects to consider, you can use healthcare solution development services by Lemberg Solutions.

What is Compliance in Healthcare?

Compliance in healthcare serves as a cornerstone in care quality. It is a set of regulations that ensures healthcare services are delivered ethically and properly. Following the compliance rules, healthcare providers not only commit to delivering high-quality services, but also reduce the risk of legal penalties. Altogether, it ensures a better care quality delivered to patients.

This set of standards and regulations, established by the government, is aimed at ensuring patient safety and confidentiality. It covers a wide range of practices such as:

  • secure patient records handling;
  • accurate treatment dosing and timing;
  • patient privacy and confidentiality;
  • quality control
  • employee education;
  • risk management.

The key compliance regulations in healthcare in the United States include the Health Insurance Portability and Accountability Act (HIPAA), which mandates the protection of patient health information, and Health Information Technology for Economic and Clinical Health Act (HITECH), which boosts the adoption of electronic health records (EHR’s).

Why is Compliance Important in Healthcare?


If you have wondered why is healthcare compliance important, the answer is simple. It’s not just about following laws; it’s about earning patients’ trust.

Following the compliance rules, doctors and hospitals deliver high-quality service to patients, keeping their personal data secure. It helps to reduce errors and improve care effectiveness, which is crucial for maintaining public health. Besides, sticking to compliance rules helps healthcare providers avoid legal issues. Applying best practices in patient care, they also reduce the risk of malpractice claims.

 Examples of Compliance in Healthcare

The government of each country produces its own healthcare compliance policy. This document covers various operations such as patient care, billing, working conditions, and ethical practices. There are 7 most important compliance protocols clinics in the United States should follow. Let’s learn a bit more about them.

  • HIPAA Compliance is an act that protects patient privacy and security of patient records.
  • ICD Coding Compliance ensures accurate diagnostic coding for healthcare services and reporting.
  • FDA Regulations ensure the safety and efficacy of medical products and devices used in Healthcare.
  • OSHA Regulations are focused on keeping working conditions in healthcare facilities safe and healthy to protect healthcare workers.
  • EMTALA requires hospitals to provide emergency medical treatment to all patients, regardless of their ability to pay.
  • GDPR Compliance ensures the protection and privacy of personal data within the European Union, requiring individual consent for data use.
  • HL7 Compliance regulates the exchange of electronic health information, ensuring efficient communication across different healthcare systems.

How to Make Your Healthcare Software Compliant?

Now that you know why compliance regulations in Healthcare are important, you may wonder how to make your software compliant. Whether you’re thinking of developing a custom solution or looking for a ready-to-use one, you need to ensure that all the processes in your organization are aligned.

Here’s a list of rules to follow to ensure the software you use for healthcare business is reliable.

  1. Focus on integrating strong encryption for data transmission and storage. Ensure that access to sensitive information is strictly controlled and role-based.
  2. Regularly update the software to detect weak points.
  3. Audit your software to manage permissions.
  4. Ensure that software includes features that allow to change or delete patient data easily, complying with regulations like the GDPR’s right.
  5. Regularly conduct risk assessments and compliance audits.
  6. Make sure to follow HL7 standards for healthcare data exchange and FHIR for electronic health records.

Data Security in Healthcare: Why It’s so Important?

Healthcare is a data-sensitive sector. Since healthcare providers deal with personal treatment details, this data should be severely protected. If it falls into the wrong hands, this can result in privacy violations. As a result, data breaches can destroy trust between patients and healthcare facilities.

Thinking about why is data security important in Healthcare, the answer is it’s not about privacy alone. It’s about safety. Inaccurate or tampered results can lead to wrong diagnoses, endangering lives.

Moreover, health data is often targeted by hackers for its high value. Ensuring strong security means using encryption, role-based controls, and constantly updating a system to determine weak spots. This not only complies with laws like HIPAA and GDPR but also fosters trustful relationships between patients and clinics.

Types of Healthcare Software that Require Data Security

There are different types of healthcare software, and ultimately, all of them require data security. However, there are those, the privacy of which is unquestionable. Let’s have a closer look.

  • Electronic Health Record (EHR) systems need reliable security, as they contain patient medical histories.
  • Patient Management Systems, which track patient journeys from registration to discharge, also demand high security.
  • Prescription Management Software handles sensitive data concerning patient medications.
  • Telemedicine platforms must ensure secure communication channels.
  • Laboratory Information Systems (LIS) process and store critical diagnostic data.
  • Billing software, which handles personal and financial information, also needs strong security protocols.

Each of these software types deals with sensitive health data. Thus, businesses in healthcare must implement recent anti-fraud practices to prevent data breaches, maintain patient privacy, and comply with legal standards like HIPAA and GDPR.

What Types of Protected Health Information are at Risk?

The sensitive information in Healthcare covers a wide range of data. It’s called Protected Health Information (PHI) and includes any detail that can be used to identify patients. The examples are patient’s names, addresses, and birth dates. Here’s a broader list of data that fall under PHI:

  • Medical records, as they contain treatment histories, diagnoses, and medication information.
  • Lab test results, which reveal important health insights, also need protection.
  • Insurance information is crucial as well, as it includes financial and personal data.
  • Photos or videos taken during medical procedures, often used for education or diagnosis, are sensitive.
  • Emails and texts between patients and healthcare providers, containing personal health discussions.
  • Even minor details like appointment dates and billing information can be misused if leaked.

Thus, healthcare facilities need to constantly update the software they use for storing information, as data leaks can threaten patients’ privacy and security.

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