When developing a healthcare application for the U.S. market you're entering a promising yet challenging field. Any digital product that handles sensitive U.S. patient health information (PHI) must adhere to industry standards, such as the Health Insurance Portability and Accountability Act (HIPAA).
HIPAA, applies exclusively to apps created for the U.S. This federal law is designed to safeguard patients' sensitive health information known as PHI, and its digital version is known as electronically Protected Health Information (ePHI).
If your healthcare application handles US patient data anyhow you have to follow HIPAA regulations.
To make it more clear, we've put together a handy HIPAA-compliant app checklist for 2023. It will guide you through the essential principles your software should adhere to, ensuring data security and legal compliance for your app.
What does HIPAA stand for
The primary objectives of HIPAA are:
- Keep patient health information confidential.
- Give patients the right to access their own health information.
- Give patients the right to choose how their health information is used and shared.
So it is all about making sure that sensitive patient information (PHI) remains private and undisclosed.
PHI includes a wide range of data, such as medical records, insurance details, billing information, and even video or audio, between patients and healthcare professionals or organizations (covered entities). Each covered entity dealing with Protected Health Information (PHI) must adhere to HIPAA compliance.
The following data types fall under HIPAA compliance:
Ensuring HIPAA compliance is crucial for any healthcare software development, medical system creation, or services provided to healthcare organizations.
Failure to follow HIPAA regulations can have serious results, including significant financial losses for the business, damage to your reputation, and a loss of trust from patients. Violations can lead to fines ranging from $100 to $50,000 per record.
Who needs to be HIPAA compliant?
HIPAA primarily applies to covered entities like insurance providers, healthcare programs, hospitals, pharmacies, nursing homes, dentists, and healthcare billing services. It also extends its reach to business associates, which refers to individuals or organizations that work for or provide services to these covered entities.
Below we break down the two types of businesses that must comply with HIPAA regulations.
What is a covered entity?
A covered entity is an organization legally required to comply with HIPAA rules.
Examples of a covered entity include:
- Health care providers
- Health insurance companie
What is a business associate?
A business associate provides services to a covered entity and has access to PHI.
Examples of business associates include:
- Data storage firms
- Billing companies
- Cloud service providers
- CPA firms
So, if your Healthcare app deals with confidential patient data, you’re likely to fall under the category of a business associate.
Types of healthcare apps that fall under HIPAA compliance
Now you know that healthcare apps that intend to store, record, or share PHI must adhere to HIPAA regulations. Examples of healthcare and mHealth apps that require HIPAA compliance include:
- Telemedicine or secure/private messaging apps
- Electronic Health Record (EHR) apps
- Healthcare apps that collect data for or communicate with healthcare providers
- Medical records or lab results apps
- Patient monitoring apps or medication compliance apps when connected with physicians
Healthcare software developers must understand the specific security controls and workflows mandated by HIPAA, such as PHI removal.
However, not all mHealth apps need to comply with HIPAA. The Office of Civil Rights (OCR) clarified that HIPAA regulations have limitations in regulating third-party health apps chosen by patients and not directly connected to or used by physicians—unless the app developer is considered a covered entity or business associate.
Examples of mHealth apps that may be exempt from HIPAA regulations include:
- Wellness Apps: Apps that are primarily designed for general health and wellness tracking, such as fitness apps, nutrition trackers, or meditation apps, may not fall under HIPAA if they don't involve the collection, storage, or transmission of PHI. However, if they collect and store health data, users should be informed about their data privacy practices.
- Pharmacy and Medication Reminder Apps: Apps that remind users to take medications or help manage prescription refills may not need to be HIPAA-compliant if they do not store detailed medical records or PHI.
- Mental Health Apps: Apps designed to provide mental health support, mood tracking, or stress management may not require HIPAA compliance if they don't involve PHI storage or transmission. However, user privacy and data security remain important considerations.
- Wearable Health Devices: Devices like fitness trackers and smartwatches are generally not subject to HIPAA, even if they collect health data, as long as they do not transmit this data to healthcare providers or store it in a way that links it to specific individuals.
The good news is that while HIPAA compliance is crucial for certain healthcare apps dealing with PHI, many mHealth apps fall outside its regulatory scope, allowing for greater flexibility and innovation in the mobile health industry.
HIPAA Compliance Requirements
HIPAA defines 5 significant rules that all healthcare software applications must follow:
1. HIPAA Privacy Rule
The rule protects the use and disclosure of ePHI, giving patients certain rights to access and control their health data. It applies to health plans, certain healthcare providers, and healthcare clearinghouses. The Privacy Rule restricts the use and disclosure of ePHI, permitting it only in specific cases:
- When the Privacy Rule allows or requires it.
- When individuals (patients) provide written authorization.
Required disclosures include providing individuals access to their PHI and reporting to HHS (United States Department of Health and Human Services) during compliance investigations. Permitted uses and disclosures encompass:
- Providing PHI to the individual.
- Utilizing PHI for treatment, payment, and healthcare operations.
- Giving individuals the option to agree or object to disclosure.
- Incidental use and disclosure, restricted to the "minimum necessary."
- Engaging in public interest and beneficial activities, not mandating individual consent for 12 national priority purposes.
- Employing limited datasets (PHI without identifiers) for research, public health, or healthcare operations.
2. HIPAA Security Rule
The HIPAA Security Rule defines three types of safeguards — administrative, physical, and technical. These safeguards make sure that electronic PHI stays private, accurate, and accessible.
Let's explain the meaning of each safeguard below:
Administrative safeguards help guide employees on how to properly use and store PHI.
In this case, covered entities are required to appoint a security officer, create a security management process, and ensure safe, role-based access to sensitive information. This includes training staff, assessing compliance with security rules, and evaluating risks.
In custom healthcare software development, this means:
- Risk Assessment: It's crucial to predict potential vulnerabilities and prevent data breaches. A security officer is responsible for this.
- Contingency Planning: After identifying risks, you must plan to protect PHI and create an emergency response strategy.
- Role-Based Access: This ensures that only authorized parties can access data, preventing unauthorized access.
- Security Training: Training your staff to recognize cyber threats and take precautions is essential. This includes regularly testing your contingency plan and reporting incidents.
Physical safeguards are in place to secure the physical points of access to PHI.
These safeguards establish guidelines for how employees should maintain security over their workstations and mobile devices to protect sensitive information.
Typical physical safeguards involve controlling facility access through measures like surveillance cameras and ID badges, as well as defining the correct and incorrect usage of technology.
Workstation Security: This means making sure that workstations with ePHI have safeguards like security systems, video surveillance, locks on doors and windows, and secure placement of servers and computers.
Personal Device Security: When people access ePHI on their personal devices like smartphones, they need to follow the organization's security policies. For example, if someone leaves their job, they should remove ePHI from their personal mobile devices.
Technical safeguards in healthcare software development focus on technology measures ensuring secure access, audit trails, data integrity, and secure data transmission. Here's how they apply:
Access Controls: Ensure secure user authentication and emergency access. Emergency access is vital when a system is damaged or inaccessible. Unique access to each user is granted through methods like passwords, smart cards, keys, or biometric data.
Audit Controls: Implement hardware, software, and procedures to monitor system activities involving protected data. Establish a technical infrastructure and perform risk analysis to determine suitable audit controls for your systems.
3. HIPAA Enforcement Rule
Outlines how the Department of HHS enforces HIPAA. HHS regulators decide who's responsible and calculate fines for not following HIPAA rules. They often investigate based on complaints or data breaches, but they can also initiate investigations without a specific reason.
4. Breach Notification Rule
Outlines what to do in case of a data breach. It acknowledges that no system is completely hackproof and emphasizes the importance of having a clear plan for emergencies. This rule specifies how to inform affected patients and the actions to take to minimize the harm caused by the breach.
5. Omnibus Rule
The Omnibus Rule, introduced in 2013 as the latest addition to HIPAA, brings significant changes to the Privacy, Security, and Enforcement Rules. It toughens regulations, making it more challenging to avoid breach notifications, holding business associates accountable for compliance, and imposing stricter privacy restrictions on the use of PHI.
Our HIPAA Compliance Checklist For Software Development
Secure access control
Controlling access to medical software is a crucial step in ensuring the protection of patient data. While software may deal with a lot of PHI, not everyone on your team needs access to all of it. To keep things safe, you can use a system that gives people access only to the information they actually need for their work. This way, you're protecting the data from both mistakes and any bad intentions.
- Role-Based Access Control
- Secure Password Policies
- Automatic Logout
- Up-to-Date Antivirus Software
Ensure secure authentication
One of the key elements of HIPAA Compliance is limiting access to PHI to authorized individuals exclusively. To achieve this, you need to employ user authentication and authorization measures on your platform. This involves:
Multi-factor Authentication: This trustworthy method requires users to provide not only a login and password but also an extra piece of information, like a one-time password, for added security.
Biometrics: If your employees use mobile devices, tablets, or laptops with fingerprint or facial recognition sensors, you can use biometric authentication for added protection.
Expiring Passwords: It's important to ensure all users have strong passwords. Also, regularly changing passwords can enhance security, especially against former employees or potential hackers.
Risk-based Authentication: This is a complex process where a system calculates a risk score each time someone tries to access it. It considers factors like access attempts, devices used, IP addresses, location, and more. If something seems off, the system asks for additional verification.
Physical Identification: These can be physical cards or electronic keys stored on secure memory cards that users activate with a password. These keys or tokens cannot be easily copied or hacked.
Back up your data
HIPAA requires that all ePHI be securely stored. This suggests the regular generation of backups for patient information, data, photos, and more. To ensure software compliance with HIPAA standards, software providers should prioritize the following factors:
Duplicate: Keep at least three copies of your data and store them in two different places. This helps protect against data loss.
Encrypt: Encrypt all data to keep it safe. For the highest level of data security, applications should utilize the 256-bit AES encryption protocol and two-factor authentication.
Safe Transfer: Before sending data to social programs or cloud services, make sure it's encrypted with 256-bit AES. This way, even if a file accidentally gets on a server, the info inside stays private
Set up an activity-tracking system
Keeping an eye on who's accessing your networks is crucial. A tracking system not only helps prevent breaches but also aids in post-incident investigations. By recording all user actions and IDs, you can easily identify the source of any security incidents or breaches, and ensure HIPAA compliance.
- Audit controls and activity logs
- Automatic log-offs
- Controlling access in emergency cases
- Keeping a record of any changes made to stored data and when they occurred.
Ensure secure data transfer and storage
HIPAA mandates that all PHI must be encrypted both when it's in transit and when it's at rest, whether on physical servers or in the cloud. Physical servers can be costly and less secure. Opt for a HIPAA-compliant cloud service like Dropbox or Google Drive, which provides built-in security measures.
- Use encrypted communication protocols
- Use only HIPAA-compliant cloud providers
- Utilize secure file transfer protocols like SFTP (SSH File Transfer Protocol) or SCP (Secure Copy Protocol)
- Provide the capability to block access from devices using insecure communication methods.
As far as you can see ensuring compliance with HIPAA and other relevant industry laws, regulations, and standards is a crucial thing of custom healthcare software development.
At Krootl, we have a proven track record in developing HIPAA-compliant software solutions.
If you're thinking of making an application that falls under HIPAA requirements, our expertise can provide valuable guidance along the way.