The document provides a comprehensive guide on HIPAA-compliant app development for the healthcare industry, emphasizing the necessity of securing patient data and adhering to regulations to prevent unauthorized access and data breaches. It outlines key HIPAA rules, compliance checklists, and features essential for developing secure healthcare applications, while also noting the potential penalties for non-compliance. The guide concludes by stressing the importance of proper implementation and ongoing maintenance to ensure compliance and protect patient privacy.

1. 1/12
HIPAA-Compliant App Development Guide for the
Healthcare Industry
successive.tech/blog/hipaa-compliant-app-development-guide/
In healthcare app development, it is crucial to ensure the security of patient data, aligning
with industry regulations and guidelines. Unauthorized access, network vulnerabilities, and
data theft are some of the primary issues most healthcare industries and medical service
providers encounter. As a result, implementing the Health Insurance Portability and
Accountability Act (HIPAA) becomes an unquestionable requirement for secure and credible
HIPAA-compliant app development.
Pharmacy chains, medical centers, group health plans, hospital chains, and small healthcare
service providers are all subjected to the EMR HIPAA compliance checklist. Violating these
can lead to heavy penalties and, most importantly, loss of reputation in the healthcare
marketplace.
The Health and Human Services (HHS) Office for Civil Rights (OCR) settled or imposed a
civil money penalty in 137 cases, summing up the penalty amount of $136,918,772.00.
Hence, a healthcare app must adhere to HIPAA-compliant software development guidelines
in this mobile-first era. These compliances are crucial to protect the healthcare industry and
its users from misusing the data.

2. 2/12
What is HIPAA Compliance?
HIPAA, a US federal law, has become universal rules and regulations that must be followed
by businesses that fall under its purview. HIPAA rules aim to ensure patients’ health data
security and safe management while combating abuse, fraud, and waste in health insurance
and healthcare delivery. This results in improved access to long-term care services and
health insurance.
If your healthcare application comes under HIPAA-compliance software development
guidelines, you must comply with this law as a reliable business owner. Otherwise, you will
risk a heavy penalty by HHS. As medical providers strive to meet the demands of healthcare
consumerization, you can hire a healthcare app development company to kickstart your
healthcare digital transformation journey with HIPAA-compliant app development.
The Importance of HIPAA Compliance
Healthcare mobile apps lacking security measures and standards can lead to cybersecurity
breaches or data leaks, posing additional risks of compromising users’ security and privacy.
However, data encryption, proper security standards, and access controls can prevent most
of these risks. Therefore, HIPAA-compliant app development is essential for helping both
healthcare institutions and patients.
For Healthcare Service Providers
If healthcare service providers, generally called covered entities, build software or
applications that fail to follow HIPAA law, they will be held liable to pay a considerable
penalty. Moreover, patients or your consumers are likely to trust applications compliant with
HIPAA as they trust that their data is handled securely and confidentially.
For Patients
Patients have the complete right to their medical details and can decide when and who can
access them. However, this sensitive information is widely shared and utilized for various
reasons, such as treatment plans, insurance claims, billing, etc. Therefore, patients should
only trust companies following HIPAA compliance for web applications as they will ensure
high confidentiality and privacy levels for patient information.
When Your Healthcare Apps Should Comply With HIPAA
Not all healthcare applications need to be HIPAA compliant. Therefore, a thorough study and
understanding of app objectives is necessary to determine whether it should comply with
HIPAA. On the other hand, if your healthcare application uses Protected Health Information
(PHI), it should follow the EMR HIPAA compliance checklist.

3. 3/12
Here are the entities and healthcare services that may handle PHI and, therefore, must
comply with HIPAA rules.
Covered Entity
By following HIPAA compliance for web applications, you can protect your/my/everybody’s
medical services information, i.e., PHI. Covered entities are directly involved in safe storing
and transmitting PHI, and HIPAA laws apply to these businesses, including:
1. Health plans
2. Health care clearinghouses
3. Health care providers
4. Medicare prescription drug card sponsors
5. Business associates (individuals or entities that handle PHI)
Data
Next, you must understand the type of data your mHealth collects, shares, and processes to
determine whether the HIPAA guidelines are compulsory for the development process or not.
Here are the types of data subject to HIPAA compliance, and if your application falls under
any of these categories, then you must dive deeper into the app requirements and purpose.
Patient Demographics Name, address, phone number, email address, date of birth,
social security number, and other identifiers.
Medical History Diagnoses, treatment plans, medical procedures, and other
information related to a patient’s health condition.
Clinical Test Results Laboratory test results, imaging reports, and other diagnostic
findings.
Treatment Information Details about medications, prescriptions, therapies, and other
forms of medical treatment.
Billing and Insurance
Information
Billing and Insurance Information: Insurance policy details, billing
records, and financial information associated with healthcare
services.
Research Data Linked
to Identifiable
Individuals
Research data that includes identifiable information about
patients participating in studies or clinical trials.
Healthcare Provider
Identifiers
NPI (National Provider Identifier), provider names, and other
identifiers associated with healthcare professionals and
organizations.
Software Security

4. 4/12
Adhering to HIPAA regulations ensures your applications have advanced security measures
to minimize data breaches and protect patient privacy. HIPAA-compliant app development
involves a comprehensive approach to security, including access controls, audit trails, and
other measures. Hence, the technology used for the protection and control access of the
ePHI is also a contributing factor that helps to identify whether or not healthcare app
development falls under the HIPAA rules.
Physical
Safeguards
Facility access controls, workstation security, hardware inventory, and
device encryption.
Technical
Safeguards
Access controls, audit controls, integrity controls, and transmission
security.
Want to know about how AI can be a transformative technology for building a robust
healthcare app? Read our blog on the role of AI in Healthcare App Development.
Essential Rules to Consider For HIPAA-Compliant App Development
HIPAA compliance mandates the following specific rules and regulations for developing a
healthcare application that stores and processes ePHI.
Let’s understand the crucial rules and terms under HIPAA compliance:
Privacy Rule

5. 5/12
The HIPAA Privacy Rule safeguards individuals’ medical records and health information held
by covered entities by setting limitations on uses and disclosures without patient
authorization. Thus, it protects PHI (electronic, oral, or paper) collected or transmitted by a
covered entity, granting individuals rights to access and correct their health records.
Security Rule
This rule applies to ePHI to prevent data misuse or leaking, guaranteeing sensitive
information’s confidentiality, integrity, and security. This practice implements administrative,
physical, and technical protection measures with vulnerability assessment and preventive
measures like data encryption, authorization, access control, and proper disposal methods.
Breach Notification Rule
Under the breach notification rule in HIPAA, the covered entities and their business
associates are bound to notify individuals like patients or HHS and media of breaches
disclosure of PHI. Any impermissible use or compromising privacy and security of PHI
involving less than 500 individuals must be notified to HHS within 60 days.
On the other hand, if the breach affects over 500 individuals, covered entities must notify
media outlets along with HHS up to 60 calendar days.
Enforcement Rule
The HIPAA Enforcement Rule comes into action when ePHI has violated the provisions
related to investigations, penalties, and enforcing compliance with the HIPAA rules.
Moreover, it works unitedly with the Privacy Rule, Security Rule, and Breach Notification
Rule for proper monitoring and enforcement.
It contains rules and regulations on investigations, penalties for non-compliance, criminal and
civil penalties, corrective action plans, resolution agreements and settlements, and appeals.
The Omnibus Rule
The HIPAA Omnibus Rule issued by the US Department of Health and Human Services
(HHS) became effective in 2013, introducing significant changes and updates on HIPAA
regulations. This rule mainly expanded the direct liability of business associates for
compliance with certain HIPAA Privacy and Security Rule provisions.
With the enhancement of breach notification rules, individual rights, Genetic Information
Nondiscrimination Act (GINA) amendments, and security and privacy rules, it strengthens
HIPAA privacy and security protections.
Follow the HIPAA Compliant App Development Checklist

6. 6/12
Since HIPAA compliance is an ongoing process, the checklist is part of a broader strategy
that includes regular training for staff, updates to policies and procedures, and staying
informed about regulation changes. Additionally, consulting with legal and compliance
experts in a healthcare app development company is advisable to ensure your app fully
meets HIPAA requirements.
Step 1: Determine the Privacy and Security Requirements
Conduct a comprehensive risk assessment to identify potential threats and
vulnerabilities.
Classify data handled by the app for implementing targeted security controls.
Ensure that the app’s features and functionalities align with HIPAA requirements.
Step 2: Implement Security Measures and Technical Protections
Encrypt data to secure it during transmission and at rest.
Implement access controls to restrict access privileges.
Keep systems and applications up to date with the latest security patches.
Step 3: Manage Associate Agreements
Verify business associates comply with the Business Associate Agreement (BAA)
terms.
Educate business associates on HIPAA regulations, emphasizing their roles.
Regularly update BAAs to maintain business practices and legal requirements.
Step 4: Execute Breach Notification Plan
Categorize incidents to guide the appropriate response.
Outline communication protocols within the breach notification plan.
Regularly test the breach notification plan to ensure its effectiveness.
Step 5: Conduct Compliance Audits
Clearly define the scope and objectives of the compliance audit.
Schedule compliance audits to identify potential areas of non-compliance.
Document the results of the audit for corrective action.
Step 6: Assess and Mitigate Audit Risks
Identify potential risks associated with the audit process that may impact compliance.
Develop and implement mitigation strategies to address identified risks.
Step 7: Document Essential Policies and Procedures

7. 7/12
Develop policies that cover all aspects of HIPAA compliance.
Provide policies with clear and actionable procedures for implementation.
Update policies and procedures to align with changes in regulations, technology, or
organizational practices.
Features for HIPAA-Compliant Mobile App Development
When building a secure healthcare application that your users can trust, it is essential that
you understand the features and their complexity. However, the characteristics of HIPAA-
compliant apps vary as per their types or categories, and there are specific components that
you will implement regardless.
Let’s take a look at some of the features and how to implement them in the safest way for
HIPAA compliance.
User Identification
Implement robust user identification in your HIPAA-compliant healthcare app with a
password or PIN. Moreover, you can integrate advanced authentication features with a
Smart key or Biometric identification.
Access During Emergencies
In healthcare app development, anticipating emergency disruptions is crucial. While not
mandated by HIPAA, incorporating provisions for scenarios like natural disasters showcases
proactive planning. Ensuring uninterrupted access to critical data during such events reflects
a commitment to patient care continuity.
Encryption

8. 8/12
Continuous data encryption is imperative for heightened security, whether data is at rest or
stored on SaaS or Cloud Servers. Platforms like Google Cloud and AWS, employing
Transport Layer Security 1.2, ensure end-to-end encryption. While TLS offers robust security,
reinforcing it with Advanced Encryption Standard (AES) encryption is recommended for
added data protection.
The Process of Implementing HIPAA-Compliant Mobile App
In mobile app development, HIPAA compliance can be a challenging process, which requires
the assistance of an experienced healthcare service provider.
To become HIPAA compliant, you can follow these steps procedure.
Step 1: Implement Access Controls and Ensure Audit Trails
Restrict access to PHI based on user roles and responsibilities and maintain comprehensive
audit logs to track access and changes to PHI.
Step 2: Implement Transmission Security
Fortify data transmission security to ensure PHI’s confidentiality and integrity.
Step 3: Ensure Proper PHI Disposal
Establish secure procedures for the disposal of PHI to prevent unauthorized access or
breaches.
Step 4: Automatic Logoff Procedures
Implement automatic logoff features to enhance the protection of PHI when devices are
unattended.
Step 5: Evaluate Audit Controls
Regularly assess audit controls to identify areas for improvement and maintain a robust
security posture.
Step 6: Apply Encryption
Utilize encryption measures for both data at rest and in transit, bolstering overall data
security.
Step 7: Ensure Data Backup and Storage
Implement secure backup procedures to maintain data integrity and safeguard PHI against
potential losses.

9. 9/12
Step 8: Proof of Authenticity
Establish mechanisms to verify the authenticity of users and data transactions, ensuring the
accuracy and legitimacy of PHI.
Step 9: Train Staff and Have a Business Associate Agreement (BAA)
Educate your development and operational staff on HIPAA compliance and security
practices. Also, clearly define responsibilities and obligations regarding PHI in the BAA.
Step 10: Ongoing Maintenance
Sustain ongoing maintenance efforts to adapt to evolving threats, technologies, and
regulatory changes, ensuring the enduring HIPAA compliance of the mobile app.
Want to know more about the process of building a healthcare app? Read our blog on the
Healthcare App Development Guide.
Common Pitfalls to Avoid While Developing a HIPAA-Compliant
Healthcare App
Non-compliance with HIPAA law can occur due to internal leaks or incidents. Even if these
violations are unintentional or happen due to a lack of information/knowledge, they can lead
to vile consequences. However, these risks can be prevented through data encryption,
proper security standards, and access controls.
As discussed earlier, HIPAA has strict rules and regulations covering privacy, security, and
restrictions on covered entities. You need to avoid the following pitfalls in order to ensure
HIPAA-compliant software development.
1. Not implementing robust security measures or failing to encrypt data can expose ePHI
to potential data breaches.
2. Healthcare applications with weak access controls and authentication mechanisms can
risk unauthorized access.
3. Not being able to follow the requirements and standards regarding the disposal of PHI
can threaten the confidentiality and security of sensitive data.
4. Security vulnerabilities in healthcare applications can lead to cyberattacks.
5. Neglecting the importance of audit logs hinders the ability to detect and respond to
security incidents.
How Much Does HIPAA-Compliant Healthcare App Development
Cost?

10. 10/12
The average cost of HIPAA-compliant app development is between $45,000 and $300,000.
Many factors impact the cost of building a HIPAA-compliant healthcare app, and based on
that, you can decide the budget for healthcare app development.
1. App Complexity, including the number of features, functionalities, and interface
intricacies.
2. Implementing and maintaining security features.
3. The cost of integrating additional features and healthcare services.
4. Hiring a development team with expertise in healthcare regulations, particularly HIPAA
compliance.
5. The cost of thorough app testing contributes to the overall development budget.
6. Compliance audits, documentation, and updates.
7. The choice of development platform (iOS, Android, cross-platform) or cross-platform
development.
8. Ongoing maintenance and support are crucial for budgeting the app’s long-term
success.
9. Engaging with legal and regulatory consultants will provide valuable guidance but add
to the overall project cost.
Read our blog on Healthcare App Development Costs to know the total cost of building a
medical app.
Successive Digital: Your Road to HIPAA-Compliant App Development
As the digital healthcare solutions market rapidly expands, many companies invest in
healthcare app development services to meet patient needs and establish a competitive
edge. Successive Digital is a leading digital transformation company offering healthcare app
development services, uplifting the customer experience, and compliant with HIPAA law.
Take a look at our latest case of Modernized Legacy Healthcare Applications on AWS Cloud
under HIPAA rules and regulations. In this project, our team ensured data is stored,
transmitted, and shared for interoperability under HIPPA guidelines, along with smooth and
error-free cloud deployments. With our end-to-end cloud solutions, we improved and
modernized the infrastructure of our client’s healthcare services available to everyone. We
leveraged the latest technology, implemented HIPAA compliance, and established quality
control measures to ensure seamless telehealth solutions.
Conclusion
We can conclude that HIPAA was developed to secure the privacy of patient data and
safeguard healthcare applications, systems, and businesses in general. Furthermore, any
application that falls under HIPAA compliance but is not implemented correctly can face legal

11. 11/12
repercussions, including massive penalties of a few thousand to million dollars, depending
on the size of the security or data breach. Hence, following all these HIPAA procedures and
processes for robust healthcare app development is necessary.
FAQs: HIPAA-Compliant App Development
No, there is no such certification as HIPAA certification, but you need to take HIPAA
compliance into consideration while building a healthcare app. This means that your system
or application will adhere to all sets and subsets of HIPAA guidelines, and then you will be
able to build a HIPAA-secure app. Concerned authorities set such rules and regulations to
boost healthcare applications’ data security and infrastructure.
Here are the step-by-step instructions for building a HIPAA-compliant healthcare app:
Step 1: Define Your Healthcare App Idea:
Clearly define the purpose and functionality of your healthcare app.
Identify the specific features that will involve the processing of protected health
information (PHI).
Step 2: Choose a Healthcare App Development Service Provider:
Select a reputable development service provider with experience in healthcare app
development.
Ensure the provider has a good understanding of HIPAA requirements.
Step 3: Check Whether Your Idea Falls Under HIPAA Compliance:
Conduct a thorough risk analysis to determine if your app falls under HIPAA
regulations.
Understand the specific rules and requirements applicable to your app.
Step 4: Encrypt All Transferred and Stored Data:
Use strong encryption algorithms for both data in transit and data at rest.
Implement secure transmission protocols (e.g., TLS) and robust encryption
mechanisms.
Step 5: Test and Maintain the App for Security:
Conduct regular security assessments and penetration testing to identify vulnerabilities.
Establish a plan for addressing security vulnerabilities promptly.
Implement security patches and updates regularly.

12. 12/12
Any healthcare application that store or process ePHI (created, received, used, and/or
maintained by covered entities) need to comply with HIPAA regulations. Therefore, defining
your app idea and target audience is extremely crucial to determine whether or not it falls
within HIPAA compliance.
Here are some of the applications subjected to HIPAA regulations, depending on the
features and functionalities.
Telemedicine (Doctor-On-Demand) Apps
EHR Apps
Mobile Health (mHealth) Apps
Medical Imaging Apps
Prescription Management Apps
Remote Patient Monitoring Apps
Healthcare Messaging Apps
Healthcare Learning and Training Apps
Appointment Scheduling Apps
Population Health Management Apps
A cloud-based healthcare app processes and/or stores ePHI for a covered entity or another
business associate, and therefore, it must be HIPAA compliant. Stored or transmitted data
through cloud service providers like Google Cloud and AWS provide end-to-end encryption
and utilize Transport Layer Security(TLS). However, to facilitate an additional layer of
security and further strengthen data encryption, a reliable healthcare app development
company must implement Advanced Encryption Standard (AES) encryption.
The US Dept. of Health and Human Services imposes strict civil and criminal penalties in
case of HIPAA violations, ranging from $100 to $50,000 per violation as per the tiers.
Therefore, HIPAA-compliant mobile app development is mandatory for your healthcare
business to avoid any issues in the future.
What will happen if you violate HIPAA? It is likely that you will be penalized by OCR
financially, depending on the severity of the violation.
However, there is a possibility that a business or healthcare service provider was not aware
of the HIPAA regulation, resulting in a data breach. In such cases, OCR might resolve HIPAA
violations as per voluntary compliance, corrective action, and/or resolution agreement.
Hence, covered entities will get to address areas of non-compliance. However, in the case of
serious violations or persistent negligence, financial penalties may be imposed.