$4.3 million (maybe even more) to be paid in penalties. This might be the verdict you’ll hear in court one day if you reject the need for developing apps in a HIPAA compliant telemedicine manner. This is a real-life case that we’re talking about. A cancer center from Texas, which we’ll leave undisclosed, recently paid $4.3 million in civil monetary penalties because it failed to safeguard its patients’ data the way HIPAA instructs and requires. This confirms the serious risks of being non-compliant.
The investigation conducted by the Office of Civil Rights showed that the center failed to use proper encryption on three devices that kept 34,000 patients’ protected health information (PHI) records in accordance with HIPAA requirements. Whenever you think about why HIPAA compliance is one of the first boxes to tick off the list of your healthcare app’s features, think of the risk of regulatory fines you can pay if you don’t. Now that we have your attention, let’s move on to an instructive and practical guide on how to develop HIPAA compliant software for telehealth in 2025.
Achieving HIPAA compliance is the first step toward building trust. Are you struggling to define your HIPAA compliance roadmap and integrate the necessary data security features into your product? Contact our compliance experts to ensure your platform adheres to the latest regulatory requirements!
Table of Contents
What is HIPAA? Answering the Primordial Question
Some folks still find it hard to understand why developing HIPAA compliant telemedicine apps is crucial. The Health Insurance Portability and Accountability Act of 1996 (HIPAA), is one of the most crucial milestones achieved by the United States Government in modernizing the country’s healthcare systems. Signed into laws and regulations on the 21st of August, 1996, HIPAA changed the way of collecting, maintaining, governing, and, most importantly, safeguarding patients’ personally identifiable information.
Signed into law on the 21st of August, 1996, HIPAA has changed the way of collecting, maintaining, governing, and, what is more, protecting patients’ personally identifiable information. This Act has once and forever altered the information flow patterns within healthcare systems worldwide.
HIPAA makes it crystal clear that the healthcare and healthcare insurance industries must protect their patient data, or protected health information (PHI), as well as electronic PHI (e-PHI), from intrusion and misuse. This sensitive data might be used to cause serious damage. Hence, the government has passed this law to ensure HIPAA compliance for every company providing services used in healthcare and collecting any data from their customers.
4 Key Rules for HIPAA-Compliant Software Development
When it comes to HIPAA compliant telemedicine development, there are four major compliance requirements that you have to adhere to in 2025:
- The Privacy Rule. This rule assures that clients’ PHI is adequately safeguarded while smoothly transmitted between authorized parties. It establishes a rigid set of rules regarding a client’s rights to manage how their identifiable PHI is stored and used. To comply with HIPAA, all covered entities and business associates must define their policies and procedures for PHI usage.
- The Enforcement Rule. Codified under 45 CFR Part 160, Subparts C, D, and E, this rule imposes the need for holding the covered entities accountable by applying financial penalties and court procedures to the violators of HIPAA violations.
- The Security Rule. It is to be found at 45 CFR Part 160 and Part 164, Subparts A and C. This rule features the HIPAA Administrative Simplification provisions defining the national standards for the security of e-PHI, focusing on administrative, physical, and technical safeguards. It is the core guide for building HIPAA-compliant software.
- The Breach Notification Rule. As described at 45 CF, §§ 164.400-414, this rule requires all HIPAA-covered entities to notify their stakeholders and anyone involved in the e-PHI storage and management process of a possible or actual data breach. This aspect of breach notification is vital for maintaining HIPAA integrity.
These four rules frame your overall healthcare compliance strategy. You have to make sure that the e-PHI is properly protected following the standards laid out in 45 CFR Part 160 and Part 164, Subparts A and C. Yet, if a breach happens, you have to report it and respond to it. Otherwise, get ready for the penalties envisaged by 45 CFR Part 160, Subparts C, D, and E.
While everything might seem clear – follow the holy four and you’ll be safe and sound – developing HIPAA compliant software is complicated. Software vendors need practical steps. SPsoft decided to take a revolutionary approach by providing a practical checklist based on our work with leading healthcare organizations. We’ll take you right behind the scenes of developing a HIPAA-compliant app for the telemedicine industry.
How We Build HIPAA-Compliant Telemedicine Software at SPsoft
It was not long ago that a US-based telehealth start-up, called Switchback Health, contacted us in search of help. Their previous tech partner has abandoned the platform with an extensive tech debt to deal with, including HIPAA compliant telemedicine and cybersecurity issues.
- Switchback Health is a neoteric telehealth platform for physiatrists and recuperative care patients that makes the treatment process easier. Strangled by the COVID-19 pandemic limitations, patients and doctors required a new way of ensuring the continuity of the needed recuperative care.
- With the help of Switchback Health, instead of visiting a doctor’s office, patients get a personalized set of recuperative exercise videos, which doctors can adjust and update. This is an up-and-coming HIPAA compliant telemedicine project called to refine the healthcare delivery process.
The years of cumulative experience gathered behind our team members’ backs has cleared the way for a swift and yet efficient implementation of the project. Nonetheless, developing HIPAA compliant telemedicine always starts with an extensive R&D session.
Having scrutinized the architecture and infrastructure left behind by the previous vendor, we have identified the fundamental need to refactor the code, architecture, and infrastructure from scratch to render the platform compatible with AWS ABB and App Store requirements.
Your Checklist for HIPAA Compliance in Software Development
We have come up with a stepwise guide for HIPAA compliant telemedicine apps. Yet, if you feel like you could use a bit of expertise, you can always count on us. You need to follow three significant steps to reach the state of HIPAA compliance in software development. Adhering to this software development algorithm will ensure your project’s conformity to each of the four HIPAA rules mentioned above.
Analyze the Risks
It seems pretty easy to understand what is meant by the term “risk analysis.” Yet, there is no unified approach to it, as we all comprehend the concept of risk in various conjunctures. Thus, you have to identify the possible threats to the confidentiality, security, and integrity of the client’s medical information stored and transmitted within the app you develop. This step involves thorough risk assessments and should be documented.
- Check the data’s source, cloud storage & maintenance environment, and transmission destinations.
- Define the data classes involved.
- Research and evaluate the PHI security practices used by the industry leaders.
- Detect the potential vulnerability associated with infrastructure weaknesses.
- Analyze and adjust the scrutinized security practices to your project’s needs.
- Predefine and assess the consequences in a case of a PHI breach.
- Develop and document the PHI/e-PHI response plan.
As you’ve been reading through this list, you might have, probably wondered about the data classes that we mentioned. Defining the data classes featured within the app is actually an important step that many software vendors miss. In accordance with the United States Department of Health and Human Services, there are 18 personal data classes that can be construed as PHI/e-PHI when combined with healthcare data. Those are:
- The patient’s name
- Patient-related dates, e.g. date of birth/death, admission/discharge
- Geographical information on the patient’s domicile
- Emails
- Phone numbers
- Fax numbers
- Social Security number
- Medical record number
- Health plan beneficiary numbers
- Bank account numbers
- Certificates & license numbers
- Vehicle identifiers and serial numbers
- Device identifiers and serial numbers
- Web URLs
- IP addresses
- Biometric identifiers, including finger and voiceprints
- Full-face photographic images and any comparable images
- Any other unique identifying number, characteristic, or code
Even when taking over a platform like Switchback, we ran the initial risk assessment to ensure we eliminated every issue on our way to HIPAA compliance.
Eliminate the Risks
As soon as you have the assessment results, you’re ready to eliminate all the risks that might affect your project, even theoretically. The best approach to apply here would be starting from scratch. That is, commence training your teams on cybersecurity, gradually moving to introduce the HIPAA-specific concepts.
- Implement HIPAA Training. Commence training your teams on cybersecurity, gradually moving to introduce the HIPAA-specific concepts. This HIPAA training is non-negotiable.
- Apply Minimum Necessary Requirements. Visit the HHS website to learn the minimum necessary requirements for PHI usage and disclosure.
- Adopt Technical Safeguards. Ensure core security measures are in place, such as two-factor authentication and strong encryption of patient data. Access control mechanisms, particularly role-based access, are essential to safeguard data.
When we started working on Switchback, we already knew what we were doing. Hence, having teamed up with High Tower Security, the SPsoft team has provided R&D services, technology consulting, as well as architecture and infrastructure updates. Those were vital for refining the product’s functionality and security and ensuring it could meet HIPAA requirements.
We also dealt with the tech debt left behind by the customer’s previous technology partner, like refactoring the outdated iOS code that prevented the app from meeting the updated App Store requirements, thus clearing up the way for further product development. Adding the automated SSL certificates and a custom-designed referral program, we have exterminated a myriad of the app’s legal and customer experience discrepancies.
3. Manage Risks in Advance
Ensuring your platform’s security in advance is good. However, making sure it will remain in mint condition, in the long run, is even better. Remember, there are always hackers and other villains eager to lay their hands on your clients’ PHI/e-PHI. Maintaining HIPAA compliance requires ongoing vigilance to prevent intrusion or react instantly. There are several practices to ensure constant security and compliance of your telehealth app.
- Continuous Monitoring. Apply vulnerability scans and network event monitoring.
- Penetration Testing. Apply penetration testing at least once every three months.
- Audit Trails. Analyze audit trails to identify suspicious activity, tracking logins to see who’s logged in.
- Automate Compliance Activities. Harness tools to automate event analysis and compliance reporting. This is where HIPAA compliance automation and the best HIPAA compliance software can truly streamline your compliance efforts.
- Disaster Recovery. Devise Backup & Data Archivation Lifecycles to ensure resilience and swift recovery of healthcare data.
When we were crafting Switchback’s digital battlements to withstand any potential attack, we knew it was all about the response speed. Our DevOps specialist has provided continuous support of the product’s SLA, reacting to any performance discrepancies within an hour. The product’s refactored code, coupled with the infrastructure and architecture improvements, has managed to dock the number of DevOps incidents down to zero over the course of six months.
Yet, as you might have already guessed, ensuring security is not enough; you have to uphold it.
We’ve delegated the conducting of constant penetration testing to High Tower Security. Their cybersecurity professionals have embarked on creating a long-term log collection strategy and 24/7 security monitoring, achieving a high-trust security posture for HIPAA-compliant software.
Integrating HITECH and Cloud Architecture
One of the most widespread mistakes software vendors make when seeking HIPAA compliance in software development is forgetting about HITECH. The Health Information Technology for Economic and Clinical Health Act (HITECH) provides a vital extension to the patient’s rights, ensuring they are entitled to know the parties to whom their e-PHI has been disclosed. It’s another integral part of the overall HIPAA compliant telemedicine ecosystem.
Enacted under Title XIII of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), the HITECH Act provides for the creation of a nationwide electronic health records network. It finalizes the process of putting patients in total control over their health data, which makes it essential when developing HIPAA compliant telemedicine software. A comprehensive compliance solution must cover HIPAA privacy and security rules and the HITECH mandates.
Ensuring an AWS-Based App HIPAA-Compliance
For a platform like Switchback, which uses cloud storage (AWS), signing the Business Associate Agreement (BAA) with AWS is mandatory. The business associate must then adhere to three core principles:
- High-Availability. One never knows when medical data might be needed. Hence, the software vendor must take proper care of the healthcare provider user’s ability to swiftly restore their health data in case of its loss.
- Security. The app’s data protection must continuously fall within the HIPAA-compliant framework, as the security teams must provide solutions, including encryption, intrusion detection, penetration testing, vulnerability scanning, etc.
- Resilience. All the sensible data and PHI/e-PHI, in particular, must be stored in a reliable and secure cloud storage manner.
It seems like sometimes HIPAA compliance is more about support and maintenance, as the need for penetration testing, intrusion detection, and other ongoing services shows. Therefore, when ensuring Switchback’s HIPAA compliance, we teamed up with High Tower Security – one of the most trusted partners in today’s world of cybersecurity. Thus, we were able to ensure an AWS architecture that serves the app’s security needs right.
No matter if your users install the software’s desktop version, browse the web for it, or use the product on their phones or tablets. The design and feature layout should be as consistent as possible, to reinforce confidence and ensure a positive user experience. Keep the page architecture the same wherever possible to make using your products intuitive on all devices.
Setting the AWS Architecture for a HIPAA-Compliant Telemedicine App
For the purely technical part of HIPAA compliant software development, healthcare organizations should follow the four rules below.
Provide Production Services in Copious Availability Zones (AZ)
Your application must be highly available. It means that a user must be able to instantly restore their health data, regardless of whether the data was stolen or the account suspended. AWS offers several availability zones to use, providing for the developers’ ability to craft EC2-based services across copious AZs. Using the EC2 auto-scaling groups and Elastic Load Balancers (ELB) is a great way to support HIPAA compliance.
Separate Development & Production Environments
Separating development and production environments is a must when developing HIPAA compliant telemedicine software. AWS offers two ways to do it. You can create development and production environments using separate VPCs or build them in separate AWS Accounts that an AWS organization manages. This way, developers’ access to the app’s data is limited to the resources required strictly for developing and updating the app. As a result, the probability of unauthorized access is being minimized.
Ensure Auditing by Collecting Logs
Preventing a data breach is the best way of dealing with it. Thus, the ability to audit suspicious activity logs is the right way to analyze the instances and come up with efficient response and prevention methods and practices. Some of the AWS verified log collection practices are AWS Cloud Trail and Access Logging for Regions and Access Logging for AWS services (S3, RDS, Redshift), respectively. Also, harnessing AWS CloudWatch to collect errors, availability metrics, and application logs would be a great idea.
Devise Backup & Data Archivation Lifecycles
A resilient cloud architecture must contain reliable backup and recovery processes, which are integral for preventing data loss and recovering the data compromised or stolen. Hence, make sure to come up with the product’s Disaster Recovery Policy that will provide the data backup and recovery standards to follow. Make sure to review it periodically, catering to its utmost technical relevance and reliability.
Geolocation, orientation sensors, camera, vibration, voice control, integration with wearable devices, and secondary screens — there should be multiple ways to deliver value to your customers using their device functionality. Controlling multimedia with voice or wrist movements, automatically connecting to any smart TV after tapping a single button, joining a network by scanning a QR code instead of manually entering the login and password — all of these are examples of adding value to your product by effectively using device functions.
Saving Our Clients
When working on the Switchback project, we made a wiser decision and implemented encryption on the AWS basis. Thus, any attempt to hack or breach our client’s patient’s data will end in failure. We also took the 18 classes of information apart and distributed them to various servers, meaning there is no correlation between the data and patients’ records. Hence, even if somebody will somehow be able to access the information, they will make no use of it, as they will not know to whom it belongs.
2025: Civil and Criminal Penalties for Non-Compliance
We did nothing else but save our client from experiencing even the slightest possibility of both civil and criminal penalties. Below is the list that reminds people and companies why it is crucial to develop only HIPAA compliant apps.
| Violation Severity | Civil Penalties (Per Violation) | Criminal Penalties |
|---|---|---|
| Ignorance | $100 to $50,000 | |
| Reasonable Vigilance | $1,000 to $50,000 | |
| Wilfully Neglected (Corrected within 30 days) | $10,000 to $50,000 | |
| Wilful Violation (Not corrected within 30 days) | $50,000 minimum | |
| Knowingly Disclosing PHI | $50,000 + up to 12 months in jail | |
| Violation Under False Pretenses | $100,000 + up to 60 months in jail | |
| Violation for Personal Gain | $250,000 + up to 120 months in jail |
Final Thoughts
Developing HIPAA compliant software is a task that requires extensive experience in building solutions that meet HIPAA and HITECH regulatory requirements. HIPAA compliance is not just a technical checklist. Instead, it’s a continuous compliance process that demands robust data security and an ongoing commitment to privacy and security standards. HIPAA compliance automation can greatly streamline this.
Fortunately, the SPsoft team can deliver on both fronts of development – technical and legal, ensuring compliance for your business and protecting against the risk of regulatory fines. Creating a HIPAA compliant telemedicine app is not a challenge but a routine for us. Yet, we make sure to address every routine with creativity and vigor.
Are you ready to build a secure, HIPAA-compliant telemedicine solution from the ground up? Let’s discuss your project’s unique compliance needs and ensure your success in 2025 together!
FAQ
What is the difference between a Covered Entity and a Business Associate?
A Covered Entity is a healthcare organization that directly provides care, handles health information, or processes claims (e.g., hospitals, clinics, insurance plans). A Business Associate is a person or entity that performs functions or activities on behalf of a Covered Entity that involves access to PHI (e.g., cloud storage providers, billing companies, software vendors like SPsoft). Both must comply with HIPAA standards.
Why must my software vendor sign a Business Associate Agreement (BAA)?
A BAA is a legally required contract that establishes how the Business Associate will safeguard PHI received from the Covered Entity. By signing the Business Associate Agreement, your software vendor agrees to meet HIPAA requirements, implement technical and administrative safeguards (like encryption), and report any potential breach. Without a signed BAA, sharing PHI with a vendor constitutes a major HIPAA violation.
How can a small healthcare practice streamline its compliance process?
Small healthcare providers can streamline their compliance efforts by utilizing the best HIPAA compliance software that offers HIPAA compliance automation. These tools help to automate the collection of evidence (automated evidence collection), conduct regular risk assessments, manage policies and procedures, and organize HIPAA training. Using a pre-audited, HIPAA-compliant platform like AWS or Azure for cloud storage also significantly reduces complexity.
What technical controls are mandatory to ensure HIPAA compliance?
Mandatory technical controls required for HIPAA-compliant software include encryption (of PHI both in transit and at rest), access control mechanisms (like unique user IDs and role-based access), automated log-off procedures, and authentication controls (such as strong passwords and multi-factor authentication). These controls are essential to secure electronic health records against unauthorized access.
What is the HIPAA Security Rule audit and why is it important?
The HIPAA Security Rule audit evaluates whether a covered entity or Business Associate has implemented the required administrative, physical, and technical safeguards to protect e-PHI. This audit is important because it identifies potential vulnerability in the organization’s security posture and is a primary requirement for maintaining HIPAA compliance. Regular auditing is essential for all healthcare organizations.
What role does SOC 2 or ISO 27001 certification play in HIPAA compliance?
While SOC 2 and ISO 27001 are not legally mandatory under HIPAA laws and regulations, they demonstrate that a software vendor or cloud storage provider adheres to high international standards for security management and data protection. This commitment to security provides significant assurance that the vendor can support HIPAA compliance and manage the sensitive data responsibly.
How often should a risk assessment be performed to meet HIPAA requirements?
The HIPAA Security Rule requires that covered entities and Business Associates conduct an accurate and thorough risk assessment periodically. While it does not specify an exact frequency, compliance experts recommend performing a full risk assessment at least annually and whenever significant changes occur in the organization’s environment (e.g., a new EHR system, new cloud storage provider, or a major system update).
Can using top HIPAA compliance software automate your HIPAA compliance?
Yes, using top HIPAA compliance software can significantly automate your HIPAA compliance efforts, particularly in documentation and monitoring. These tools often include templates for policies and procedures, automate the tracking of compliance activities, and provide centralized audit management. However, while they automate the process, they do not replace the need for human oversight and strong internal data security practices.
