Technology reshapes how we access and manage medical information. This makes it vital to safeguard sensitive health data from breaches.
The Health Insurance Portability and Accountability Act (HIPAA), enacted in 1996, transformed healthcare regulations. To understand its impact on data protection, we must examine its core principles and rules. This knowledge is especially relevant for developers shaping the future of digital health technology.
Developers must create innovative solutions while ensuring HIPAA compliance. This responsibility highlights the connection between development and regulatory standards.
Understanding their role in protecting patient data is essential. The following HIPAA compliance checklist for software development outlines key requirements. The next sections will explore these in detail.
Why care about HIPAA rules?
HIPAA establishes strict guidelines to protect the confidentiality, integrity, and security of Protected Health Information (PHI).
PHI refers to all essential patient data that falls under HIPAA’s protection. Whether in electronic form or physical records, protecting patient data is crucial in the healthcare sector. Data becomes PHI when it connects personal identifiers with an individual’s physical or mental health, medical information, or healthcare payment records.
HIPAA specifically defines PHI through a set of 18 distinct identifiers:
- Personal Names
- Address (or anything that might give away the exact location of the patient)
- Specific dates (excluding years)
- Telephone numbers
- Fax number
- Email address
- Social Security Number
- Information from medical records
- Health plan beneficiary number
- Account number
- Certificate or license number
- Vehicle license plate numbers
- The device identifies and serial numbers
- Web URLs
- Internet Protocol (IP) Address
- Voice or fingerprints
- Photographic images
Each identifier can be used to reveal detailed information about a person’s medical history and identity. HIPAA protects these elements by preventing unauthorized access to this sensitive information.
What entities do HIPAA rules apply to?
HIPAA covers three main categories of entities, each playing a distinctive role within the healthcare ecosystem. These categories encompass healthcare providers, health plans, and healthcare clearinghouses. They form the pillars of patient data protection and privacy that developers should be aware of.
Healthcare providers
Healthcare providers encompass individuals and organizations that offer medical services and care to patients. This category includes doctors, nurses, clinics, hospitals, nursing homes, and other medical practitioners.
These entities directly engage in patient care, diagnosis, treatment, and the management of health-related information. Healthcare providers must protect sensitive patient data and follow HIPAA regulations as a core part of their responsibilities.
Health plans
Health plans consist of entities that manage and provide insurance coverage for healthcare services.
This category encompasses:
- Health insurance companies;
- Health maintenance organizations (HMOs);
- Employer-sponsored health plans;
- Government programs like Medicare and Medicaid;
- As well as other insurance providers.
Health plans play a crucial role in financing and coordinating medical care for individuals and families. They collect and manage patient data to facilitate claims processing, benefit administration, and premium calculations.
Healthcare clearinghouses
Healthcare clearinghouses serve as intermediaries in the healthcare industry. They facilitate the exchange of health-related information between various entities. These organizations convert health data received from healthcare providers and other sources into a standardized format for efficient processing and transmission.
Clearinghouses ensure data conforms to standardized protocols. Thus, they enhance interoperability and reduce administrative burden. As they process and transform health data, clearinghouses must protect the confidentiality and integrity of all patient information.
These three types of entities form the foundation of HIPAA coverage, working together to protect patient health information and maintain its security. By following HIPAA rules, they help ensure patient data stays protected and maintain trust in the healthcare system. Let’s take a deeper look at the most important ones that you should be aware of.
HIPAA Privacy Rule
The HIPAA Privacy Rule safeguards patient health information by enforcing the minimum necessary principle. It mandates access controls, role-based permissions, encryption, auditing, and regular risk assessments to ensure data security and limit unnecessary disclosure.
There are 3 different requirements that you need to follow to make sure you do not break the rule of maintaining compliance with HIPAA standards:
Minimum necessary standard
You must follow the minimum necessary standard by setting up effective access controls. This means limiting each user’s access to only the PHI they need to perform their job.
By strictly following this standard you reduce the risk of unauthorized exposure to PHI. This principle prevents unnecessary access to sensitive data, limiting the potential impact of breaches or misuse.
Role-based access controls
As a developer, you have to define different user roles within your application, each with specific access privileges to PHI based on their job responsibilities.
Implement technical policies and procedural mechanisms to control access, and use robust user authentication to ensure software users can only access information authorized for their roles.
Role-based access control ensures that individuals can only access PHI that is pertinent to their job functions. This prevents overexposure to data and mitigates the chances of an accidental data breach.
Data encryption
You must protect PHI by encrypting it so unauthorized users cannot read it, even if they access the data. This requires using strong encryption for both stored data and data being transmitted.
Use protocols like Transport Layer Security (TLS) for data transmission and encryption algorithms for secure data, including cloud storage and software programs. This approach helps your application meet HIPAA Privacy Rule requirements while keeping patient health information safe.
These measures collectively create a robust security framework that fosters trust, safeguards privacy, and minimizes the potential risks associated with managing PHI.
HIPAA Security Rule
The HIPAA Security Rule protects electronic protected health information (ePHI) through electronic information systems security and physical access controls.
For HIPAA software compliance, developers must implement safeguards including:
- Risk assessments;
- Access controls;
- Data encryption;
- Usage tracking;
- Staff training.
The aim is to keep ePHI confidential, accurate, and accessible.
Here are the 3 tools that you need to employ to make sure that you promote compliance with HIPAA’s stringent security standards:
Risk assessment
Risk assessments identify vulnerabilities and threats specific to your application’s environment. Developers can best address these threats by using risk assessment tools that follow established guidelines like NIST Special Publication 800-66 Revision 1.
We recommend this tool as it educates users about information security technology within the context of the rule and directs readers to valuable information in other NIST publications.
And if that’s not enough, it helps you evaluate risks and establish a strong foundation as a developer for compliance with the HIPAA Security Rule.
Auditing and monitoring software
You have to deploy auditing and monitoring tools to track user activity, system access, and date changes. One software that you can use for this job is Splunk Enterprise Security. It offers real-time visibility into security events and user activities across the infrastructure of your medical app and overall system.
The software helps maintain HIPAA security standards and keeps patient data secure and accurate. This approach lets you quickly spot and respond to any suspicious activity, making it easier to track and fix security issues.
Security awareness training programs
Building HIPAA compliant software developers to understand how to implement security awareness training. These programs teach employees how to properly follow security policies and procedures.
Training staff about HIPAA requirements and ePHI protection helps prevent accidental security breaches. When employees understand security risks and best practices, they’re better at protecting data and keeping your application secure.
One example of a company that has successfully complied with all HIPAA rules is the Cerner Corporation. Cerner is a global healthcare information technology company that provides software solutions and services to healthcare organizations.
The company has established a strong reputation for its commitment to maintaining HIPAA compliance and safeguarding patient data. The company regularly undergoes rigorous security audits and assessments to validate its adherence to HIPAA standards.
It also provides training and resources to its employees to ensure they understand their roles in maintaining compliance and protecting against patient data breaches.
HIPAA Breach Notification Rule
The HIPAA Breach Notification Rule requires covered entities to report breaches of unsecured protected health information (PHI).
A “breach” is the unauthorized acquisition, access, use, or disclosure of PHI in a manner not permitted by HIPAA Rules.
Organizations must notify affected individuals, the Department of Health and Human Services (HHS), and the media of large breaches. It also needs to take the appropriate actions to mitigate harm. If there’s a data breach, you must notify affected people right away. If you don’t, you could face fines from both state attorneys general and the HHS’ Office for Civil Rights.
Now what does this mean for you as a developer when it comes to taking actions that do not break this rule?
Implement strong security measures
Firstly, you need to understand the breach notification rule, including its definitions, reporting requirements, and consequences for non-compliance. After understanding these requirements, your next step is to build strong security systems that keep electronic patient information (ePHI) safe from unauthorized access.
For that feel free to use data encryption, access controls, and other technical safeguards to ensure the confidentiality and integrity of electronically protected health information (ePHI). On top of that, make sure to perform regular risk assessments to identify potential threats and vulnerabilities that could lead to a breach.
Develop a breach response plan
Create a comprehensive breach response plan that outlines the steps to be taken immediately upon discovering a breach. The plan you design should include procedures for evaluating the breach, mitigating the impact, and notifying the affected parties.
Set up a system that can quickly alert everyone who might be affected by a data breach, even if you’re still figuring out how many people were impacted.
Notifications should be clear, concise, and written in plain language. Notify the HHS, and if applicable, media outlets within the designated timeframes.
Your notification letters must explain what happened in the breach and what information was exposed. They should also describe what you’re doing to address the problem and what steps people can take to protect themselves. Send the letters through secure channels to avoid further breaches or unauthorized access.
A company that experienced a HIPAA breach back in 2015 was Anthem Inc. As one of the largest health insurance companies in the US, the breach exposed the personal and medical information of nearly 78.8 million individuals.
As a result, Anthem responded by taking the following steps:
- Responded swiftly by containing the breach, involving law enforcement and its cybersecurity experts;
- Notified affected individuals;
- Investigated to determine how the breach occurred and that data was compromised;
- Implemented new enhanced security measures to address the problem;
- Paid a $16 million fine to the OCR.
HIPAA Enforcement Rule
The HIPAA Enforcement Rule establishes guidelines that aim to enforce compliance, investigation, and penalties related to violations of the HIPAA Privacy, Security, and Breach Notification Rules.
Enforced by the OCR within the U.S. Department of Health and Human Services (HHS), this rule ensures that Covered Entities (CEs) and BAs adhere to HIPAA’s regulations.
The Enforcement Rule explains how violations are investigated and what penalties apply when HIPAA rules aren’t followed. It’s designed to make sure everyone takes their role in protecting patient information seriously. It sets the framework for investigating complaints, conducting compliance reviews, and promoting voluntary compliance.
Assessing criminal HIPAA violations
The Office for Civil Rights (OCR) works with the Department of Justice (DOJ) to handle serious HIPAA violations. They protect patient privacy by investigating complaints, reviewing compliance, and providing HIPAA training.
The OCR considers certain conditions before taking action on complaints:
- The violation must have taken place within the past six years.
- The complaint targets subjects obligated to follow HIPAA, like Covered Entities (CE) or Business Associates (BA).
- The complaint should pertain to an activity proven to violate HIPAA rules.
- The complaint should be submitted within 180 days from the point when the person filing it became aware of the alleged HIPAA violation.
As a developer adhering to this rule and making sure it doesn’t come to criminal trials is quite simple. Build privacy protection into your development process right from the beginning, not as an afterthought.
Always minimize the collection and storage of sensitive patient information to what is necessary.
You also need to make sure that you implement features that allow patients to control their data, including access, modification, and deletion. Now let’s take a look at the steps you can take to do that successfully.
HIPAA Patient Access Rule
HIPAA’s Right of Access rule ensures patients can see and get copies of their health records from healthcare providers. This helps patients stay informed and make better decisions about their health care.
Healthcare providers must share records quickly and can only charge reasonable fees, though some records like psychotherapy notes are exempt. Developers need to build systems that make it easy for patients to access their records while keeping their information secure in order to ensure HIPAA compliance.
Secure data transmission
When you’re developing healthcare applications, you must use HTTPS to protect data moving between users and your app. This keeps all information encrypted and ensures transmission security.
To set up HTTPS properly, you’ll need an SSL/TLS certificate for your site or app, and you’ll need to configure your server to use it. Keep your certificates up to date and stay current with security best practices to ensure patient data stays protected as per the HIPAA compliance standards.
Design user-friendly interfaces
Prioritize the design of intuitive and user-friendly interfaces for your healthcare application. Create clear navigation paths, use consistent layouts, and ensure that users can easily access and understand the functions related to PHI.
You can implement these user-centered design principles by conducting usability testing and gathering feedback from potential users. The next step is to streamline the user interface to present relevant information prominently, such as medical records and test results.
Make sure users understand how to use your application safely by providing clear instructions and labels at every step. Add two-factor authentication to boost security without making the app difficult to use.
Business Associate Agreements (BAAs)
Business Associate Agreements (BAAs) are legal contracts required by the HIPAA that outline the responsibilities and obligations of third-party entities.
HIPAA compliance for software vendors is enforced through these BAAs. They help ensure business associates adhere to HIPAA regulations and maintain the security and privacy of PHI.
As a developer, you need to ensure that you have a signed business associate agreement in place with each covered entity you work with. The BAA outlines your responsibilities in handling PHI, including security measures, breach notification procedures, and compliance with HIPAA regulations. Review the BAA carefully, seek legal advice if needed, and make sure you fully understand your obligations.
After you know your obligations, secure the PHI you handle. This includes implementing technical safeguards such as encryption, access controls, and secure transmission methods. Keep thorough documentation of your security measures, policies, and procedures related to PHI.
Document any changes or updates you make to your systems or processes to demonstrate your commitment to compliance.
Whether you’re a startup, a Fortune 100 company or a government organisation, our team can deliver a solution that works for you.
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Conclusion
As a developer, you are responsible for protecting sensitive patient information. Failing to follow HIPAA rules can result in heavy fines, legal issues, and reputational damage, along with the loss of client trust.
By maintaining HIPAA compliance, you do more than safeguard data and meet legal requirements. You also build trust in your healthcare apps and contribute to a more reliable healthcare system.
To achieve this, you must implement technical security measures such as encryption, access controls, and secure authentication methods. Administrative safeguards, including staff training and strict access policies, help prevent unauthorized data exposure.
Proper data storage solutions ensure that medical data remains protected from breaches and loss. Audit controls allow you to monitor access and detect potential security threats.
By following these practices, you strengthen your application’s security and meet HIPAA compliance standards, ensuring patient data remains confidential and secure.
