A mobile-based application is vital for achieving digital maturity and ensuring user accessibility in the healthcare industry. That is especially true in the post-pandemic era, where patients use remote care and remote monitoring solutions. By default, such solutions access and process critical healthcare data about patients and physicians, requiring a high degree of protection. That is why HIPAA (Health Insurance Portability and Accountability Act) is essential in securing healthcare information, as the annual number of data breaches continues to drop.
The rationale behind HIPAA-compliant app development is straightforward: medical data is as valuable as credit card data, making it susceptible to various forms of fraud. Thus, healthcare app development must comply with HIPAA guidelines to safeguard against such risks. But what does this mean for software developers, hospitals, and patients? How much would it cost to develop a HIPAA-сompliant app, and what is the price of ignoring the rules? Let’s find the answers below.
“From robust encryption protocols to secure data storage and transmission, every aspect of the app’s architecture and infrastructure must align with HIPAA regulations. Our focus on technical excellence empowers healthcare organizations to leverage mobile technology while maintaining the highest data privacy and security standards in line with HIPAA requirements.”
Head of Product Management, SPsoft
“Patient privacy and data security are non-negotiable in the modern healthcare industry. By ensuring HIPAA compliance, we assure our clients that their mobile apps will safeguard sensitive health information, build trust with patients, and meet the industry’s rigorous standards.”
What is the Meaning of HIPAA Compliance for Application Developers?
HIPAA-compliant app development refers to the regulations outlined in the HIPAA when building software applications for the healthcare industry. That involves implementing security measures, privacy practices, and safeguards to protect the confidentiality, integrity, and availability of patients’ protected health information (PHI).
HIPAA compliance for mobile apps development means:
- Security measures. First, the team must implement proper technical and administrative safeguards to protect health data from unauthorized access, use, or disclosure. That may include encryption, access controls, audit logs, and regular security assessments.
- Privacy practices. The developers must ensure the app collects, uses, and shares data in compliance with HIPAA’s privacy rules.
- Business associate agreements (BAA). If the app developer handles the health data on behalf of a healthcare organization or other entity, they must enter into a BAA. This agreement outlines the app developer’s responsibilities and obligations to protect PHI and comply with HIPAA regulations.
- Risk assessments. The development team has to conduct regular risk assessments to identify vulnerabilities and address potential risks to PHI’s confidentiality, integrity, and availability.
- Breach notification. Having a procedure to promptly investigate and report any breaches of PHI as required by HIPAA regulations is vital. App developers must notify affected individuals and the covered entity in the case of a breach.
Thus, adhering to HIPAA compliance requirements is crucial for healthcare app developers to protect patient privacy, maintain data security, and avoid legal and financial consequences associated with non-compliance.
Our experts share expertise in developing HIPAA-compliant mHealth solutions. Make a deep dive into our insights to expand your view of the mHealth industry.
What is the Meaning of HIPAA for Patients and Hospitals?
HIPAA regulation is a comprehensive legislation enacted to benefit healthcare institutions and patients alike. Therefore, both parties must understand its importance and potential advantages.
Pros for Patients
Patients are the primary stakeholders, and the success of care concerns their health and their information’s safety.
- Consent requirement for patient information sharing. HIPAA compliance ensures that patient information cannot be shared without consent. Only healthcare professionals involved in patient care can share the data with relevant stakeholders.
- Restriction on forwarding patient information. As mentioned earlier, other stakeholders, such as billing departments and prescription vendors, are prohibited from forwarding patients’ information.
- Breach notification to patients. Patients have the right to be informed about a data breach. That facilitates smooth data exchange among multiple healthcare institutions while maintaining transparency.
Pros for Hospitals
The importance of developing a mobile app with HIPAA rules lies in knowing the consequences of non-compliance. Failure to adhere to HIPAA can result in substantial fines for hospitals. Data breaches can lead to significant fines, reputational losses, and even criminal penalties in case of severe violations.
Do not let incompliance hold you back. Our expert healthcare software development team will guide you through building a HIPAA-compliant app.
Protected Health Information as per HIPAA
Let’s explore the types of PHI your software should protect following HIPAA rules. Generally, any health information that can be used to identify an individual and is stored or transmitted by covered entities or business associates falls into this category. Therefore, your software should safeguard the following:
Information on the Patient’s Physical and Mental Health Condition
- Descriptions of healthcare provided to individuals
- Laboratory results, medical images, or similar data
- Names, addresses, birth dates, and social security numbers
- Admission dates, discharge dates, and dates of death
- Photos and biometric identifiers
- Contact details, like phone numbers, fax numbers, email addresses, IP addresses, etc.
- Credit card information and account numbers
- Health plan details
- Medical record numbers
Ultimately, some aspects of this information can still be accessible without requiring HIPAA protection, but only if they are not directly tied to an individual. For instance, specific data can be anonymized and available for medical research.
Expert Checklist for Developing HIPAA Compliant Apps
Despite its 114-page length, HIPAA provides no list of recommendations or best practices for encrypting patient health data or other app development considerations. However, complying with HIPAA is crucial for app developers in the healthcare industry. Since HIPAA has not undergone significant changes since 2013, its relevance is maintained by general guidelines.
But what are those guidelines exactly? We have summarized the key directives from HIPAA that you should follow during the development of a health app:
- Limit information access, implement bio authentication, two-factor authentication, and automatic log-off for inactive users.
- Assign distinct user roles with specific access rights to different app features, allowing access only to authorized users.
- Encrypt the patient data using recommended encryption standards like open-source AES 256-bit, OpenPGP, and S/MIME.
- Encrypt PHI-related data at rest and during transmission to ensure data security and prevent unauthorized access.
- Track user actions and maintain audit logs to identify users and their activities within the app. Enable unique user identification for adequate audit controls.
- Preserve the integrity of PHI by considering the use of blockchain technology for electronic health records (EHR) or electronic medical records (EMR).
- Employ secure HTTPS connections and SSL/TLS protocols when transmitting patient data to enhance security and protect against breaches.
- Collect only necessary information that improves app performance and usefulness.
- Avoid caching PHI and refrain from storing precise geolocation data beyond the state level.
- Avoid transmitting PHI through push notifications, emails, text messages, or any outside-the-app messaging channels, as they pose a higher risk of compromise.
- Back up individually identifiable health information if stored in the cloud.
- Enable patients to completely remove their personal information, including PHI data, from the system, especially in the case of lost mobile devices.
- Establish a long-term strategy to monitor all HIPAA-related aspects of your health app.
By following this checklist, developers can create a HIPAA-compliant app that prioritizes data security, privacy, and integrity in the healthcare domain.
How to Make an App HIPAA-Compliant: 5 Key Steps
Now let’s delve into the details of HIPAA-compliant app development. The following steps would be similar for telehealth solutions, chatbots, appointment apps, or any other software dealing with PHI. The details, of course, would differ, but the core steps will be the same.
Step 1. Implement HIPAA-as-a-Service Backend
In today’s interconnected world, apps are not standalone entities. Healthcare solutions are no exception. The cloud services they connect to must also be HIPAA-compliant. Fortunately, there are various options to choose from, as major cloud providers offer HIPAA-compliant backends. Such cloud providers as AWS, Truevault, and Google Cloud Platform offer such benefits.
Step 2. Separate PHI from Other Types of Data
To ensure HIPAA compliance, keeping all patients’ health information separate from other app data is recommended. By storing it in a separate database, you can avoid the need to encrypt and decrypt every byte of the app, which could impact performance.
Step 3. Full Encryption
Encryption is a crucial component of a HIPAA-compliant app. Data should be encrypted at rest (on smartphones and in the cloud) and in transit as it travels between apps and servers. This step also involves addressing the items listed in the above checklist.
Step 4. Run Security Audits and Penetration Tests
Engaging an external company to conduct comprehensive testing, including audits and penetration tests, is a good practice to evaluate the security of your app. That will help identify any vulnerabilities and ensure proper security measures are in place.
Step 5. Implement a Long-Term Strategy by Logging
Setting up procedures for ongoing monitoring of HIPAA compliance is essential because your app and its security will evolve. Establish processes to track PHI access, detect security issues, regularly reassess the effectiveness of security measures, and evaluate potential risks to the compromise of electronic protected health information (e-PHI).
These five steps outline how to achieve HIPAA compliance for your app. At the same time, the developers must keep essential features of HIPAA-compliant apps in mind.
Common Features of HIPAA-Compliant Apps
What are the typical features often found in healthcare software optimized for HIPAA compliance? Let’s check them below:
- Encryption. All PHI data should be encrypted using industry best practices. Encryption should be applied at rest (when stored on cloud or local servers) and in transit (when synchronized between applications).
- Shareable data. Patient data should adhere to HL7/FHIR data standards, enabling seamless patient information sharing among healthcare providers. Following them ensures interoperability and compatibility between different healthcare systems.
- Emergency access. HIPAA-compliant apps should incorporate emergency access functionality. That allows healthcare providers to quickly lock or export patient data in critical situations, ensuring access to essential information when time is of the essence.
- Authentication mechanisms. The software needs to implement proper authorization mechanisms to prevent unauthorized access to PHI. Robust authentication mechanisms, such as secure login credentials and user authentication protocols, help ensure that only authorized individuals can access sensitive patient data.
- Anonymization of data. A key aspect of a HIPAA-compliant health app is the ability to strip PHI and anonymize medical data. This feature removes personally identifiable information, making de-identified or obfuscated data available for research, clinical trials, and other similar purposes while protecting patient privacy.
By incorporating these features into healthcare software, developers can create a robust HIPAA app and prioritize patient data’s security and interoperability.
How Much Does HIPAA Compliant App Development Cost?
The short answer is – it depends. But to give you a rough idea, the cost of HIPAA-compliant app development can range from $50,000 to $300,000. Several factors can influence the budget for building a HIPAA-compliant mobile app, including:
- Complexity of the app. The more complex the app’s functionality and features, the higher the development cost.
- The expertise of the development company. Working with an experienced team might look like a more expensive option, but it also saves you trouble after the development is finished. Partnering with a more reliable company and avoiding additional spending on reworks and fixes is better.
- Team size. The number of healthcare app developers and specialists involved in the app development process can affect the budget. A larger team may require more resources and result in higher costs.
- Number of user roles. If the app needs to cater to multiple user roles, such as patients, administrators, and medical staff, it can increase the complexity and development effort, thus influencing the budget.
When developing a HIPAA-compliant app, it is crucial to clearly understand the core values and features that the app will provide. You can ensure a cost-effective outcome by focusing on essential features and creating a well-planned project.
How Much Does It Cost to Ignore HIPAA Compliance?
Different types of HIPAA violations vary in severity, directly determining the corresponding fines. In 2022, these fines ranged from $127 to $1.9 million. This year, the average penalty for HIPAA compliance violations is $117,184 per case, which poses a significant financial burden for most healthcare organizations.
Additionally, criminal penalties are possible, particularly for healthcare practitioners who disregard the rules or abuse their access to patient information.
- Tier 1: Violation due to reasonable cause or lack of knowledge can result in imprisonment for up to 1 year.
- Tier 2: Obtaining patient information under pretenses can lead to imprisonment for up to 5 years.
- Tier 3: Obtaining patient information with malicious intent can result in imprisonment for up to 10 years.
Loss of license, penalties, and reputational damage are other potential outcomes of HIPAA violations. That highlights the importance for healthcare organizations to prioritize secure mHealth data storage, implement robust access control measures, and collaborate with reputable providers of healthcare software services.
SPsoft Experience in HIPAA Compliant App Development
HIPAA-compliant app development needs strong expertise and strict adherence to rules. SPsoft offers experience developing HIPAA apps that strongly impact the quality of care while adhering to compliance requirements. We have already helped numerous clients, including startups and well-established healthcare software providers, designing and developing HIPAA-compliant applications that cater to the needs of both physicians and patients.
SPsoft offers R&D, technology consulting, and maintenance services to build applications that enhance the quality of care and user experience. We apply our tech expertise and a precise focus on HIPAA requirements to ensure smooth performance and eliminate legal concerns.
Mobile apps’ HIPAA compliance is essential for any healthcare organization dealing with protected patient information. Failure to implement compliant solutions can lead to severe repercussions for both clinics and individual physicians. That is why you need a healthcare software development partner with experience ensuring HIPAA compliance for your software.
SPsoft has developed HIPAA-compliant digital products for many healthcare companies. Our team will help you define the features of your solution, apply a comprehensive compliance checklist, and deliver an app that brings value to all health stakeholders following regulations.
Empower healthcare professionals and patients with a user-friendly, HIPAA-compliant app. Contact our experts to learn more about HIPAA compliance and develop your application from scratch.
To make a HIPAA-compliant app, you must ensure it follows the security and privacy measures outlined by HIPAA. That includes implementing encryption, access controls, data integrity measures, and following HIPAA guidelines for handling PHI.
Yes, apps can be made HIPAA-compliant. SPsoft experts follow a checklist that ensures your app’s full compliance with HIPAA standards preventing violations and data breaches.
HIPAA compliance means designing, developing, and implementing healthcare applications that adhere to the security and privacy requirements outlined by the Health Insurance Portability and Accountability Act. That involves implementing measures to protect patient data’s confidentiality, integrity, and availability.
HIPAA-compliant applications are healthcare software apps that meet HIPAA’s security and privacy requirements. Such applications are designed to handle PHI appropriately.