The telemedicine solutions market share is set to reach $559.52 billion in 2027, expanding at a CAGR of 25.5%. The pandemic crisis, healthcare accessibility issues, and the demand for safe and fast medical services are setting the stage for its growth. However, telemedicine app development has several nuances that companies must consider, including compliance with the Healthcare Insurance Portability and Accountability Act (HIPAA).
In this guide, we’ll explain how telehealth and HIPAA rules intersect in the US. From government oversight by groups like HHS and the FCC to the nitty-gritty of HIPAA compliance, we’ll explore how healthcare providers protect patient data.
Join us as we explain key HIPAA and telehealth rules, learn how to build HIPAA-compliant telemedicine software, highlight common slip-ups, and offer tips for building secure telemedicine software. Whether you’re a doctor, tech pro, or just curious, this guide will help you understand why patient privacy matters in our digital world.
Governmental Bodies and Regulations That Oversee Telehealth Services in the US
Several federal and state governmental bodies regulate telehealth services in the US to ensure proper patient privacy, secure technology standards, and appropriate reimbursement policies. Let’s review the central bodies and regulations.
The United States Department of Health and Human Services (HHS)
HHS oversees various agencies and laws that impact telehealth. The Centers for Medicare & Medicaid Services (CMS) sets requirements for telehealth reimbursement and coverage under federal healthcare programs like Medicare. The HHS Office for Civil Rights enforces the HIPAA Privacy and Security Rules that telemedicine platforms must follow to protect patient health data. The Health Resources and Services Administration (HRSA) provides grants and resources to promote telehealth adoption, especially in rural and underserved areas.
The Federal Communications Commission (FCC)
The FCC regulates interstate and international communications for telehealth technologies. This includes internet and broadband services required for video consultations, wireless spectrum utilized for mobile telehealth apps, and communications equipment standards for telehealth devices.
CARES Act
The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act included several provisions to expand telehealth access during the COVID-19 pandemic rapidly. These provisions include waivers to allow Medicare reimbursement for more telehealth services, funding to strengthen healthcare organizations’ telehealth capabilities, and relaxed rules to enable more healthcare providers to furnish virtual care.
State Laws and Policies
In addition to federal regulations, each state enforces specific telehealth laws. These include telehealth practice standards and clinic/provider licensing, private payer telehealth reimbursement policies, and consent requirements for virtual care delivery.
HIPAA Guidelines for Telemedicine Platforms
Signed by President Bill Clinton in 1996, HIPAA law protects patients’ sensitive medical data by regulating its processing and exchange methods.
All medical HIPAA laws are mandatory, and HIPAA-covered entities are penalized for non-compliance. The fines for HIPAA infringements are no trifle and may reach up to $2.1 million or even be followed by criminal allegations. If you are developing a HIPAA-compliant telemedicine platform, you will need to consider a number of the essential HIPAA rules you can see on the picture below. Don’t forget to familiarize yourself with HIPAA-compliant payment processing.
The HIPAA Privacy Rule, Security Rule, Enforcement Rule, Breach Notification Rule, and Omnibus Rule are the five components of HIPAA that are mandatory to develop a HIPAA-compliant telemedicine platform. Let’s find out what are the HIPAA laws in more detail.
The HIPAA Privacy Rule
The HIPAA Privacy Rule obliges all medical organizations to guard their clients’ personal health information (PHI) privacy. Telemedicine software HIPAA-compliant development firms use the concept of ePHI, which covers personal details and medical data transmitted and stored in the digital format. The statements of this rule are the following:
- Healthcare clients should have full access to their PHI, which they are free to copy, change or update it;
- An organization is obliged to respond to patients’ requests for changes and updates within 30 days;
- If a healthcare provider intends to reveal patients’ PHI data to a third party, patients should give their consent under “Notices of Privacy Practices”
Check out The US Department of Health and Human Services for more information about this and other HIPAA rules.
The HIPAA Security Rule
According to the HIPAA Security Rule, a digital system or an individual with access rights to patient data should be responsible for its security. Medical service providers must implement all the safeguards necessary to protect PHI. These safeguards fall into three categories:
- Technical. Patients’ data stored in electronic systems must be encrypted according to the NIST standards.
- Physical. Covered entities must limit physical access to data center, cloud, or server.
- Administrative. Companies should introduce procedures aimed at following HIPAA privacy and security standards. In particular, organizations should hire or train Privacy and Security Officers to ensure adherence to HIPAA standards.
Healthcare providers are subject to regular Office of Civil Rights (OCR) audits to assess risk and identify security hazards.
The HIPAA Enforcement Rule
This rule defines the size of fines and compensations that medical companies will have to pay in case their clients’ data gets revealed or stolen. The penalties vary from $100 to $50,000 per violation depending on how serious the violation is, how timely it was resolved, and whether it was done with intent. A detailed overview of compensation policies is provided later in the article.
The violations of HIPAA rules may result in criminal charges if a patient decides to sue a company for inflicted damage. Therefore, it is crucial to consider and comply with all the established policies.
The Breach Notification Rule
The Breach Notification Rule explains the procedure that needs to be followed during data leakage. Per this rule, patients should be the first to know in case of data leakage. Next, the organization must inform the Department of Health and Human Services. The notice should contain the following info:
- The type of data exposed
- The individual who unrightfully accessed PHI or to whom the data was revealed
- The type of harm inflicted
- The repercussions of a violation that were alleviated (if any)
The organization has 60 days to issue the breach notice and to inform patients about the precautions they should take to safeguard themselves from its outcomes. A covered entity must also reveal the situation to the media if a breach has negatively impacted more than 500 patients. If the privacy of less than 500 patients is affected, a healthcare company is obliged to inform an OCR portal.
Looking at the OCR’s data, many HIPAA breaches occur through email, surpassing other methods like network servers and electronic records. Of 163 incidents from January 2019 to May, 41% involved email.
While some breaches result from cyberattacks, others stem from lax email practices. HIPAA-compliant email requires access controls, authentication, audit trails, and encryption. Though not mandatory, encryption is crucial for securing data during transmission, with NIST recommending AES encryption.
The Omnibus Rule
This rule reveals all the previously unmentioned details: new definitions, policies, and compliance procedures. It also extends the list of covered entities to include third parties who must comply with HIPAA.
The Omnibus Rule introduces the umbrella term ‘Business Associates’ for all parties that may access PHI while cooperating with a healthcare firm.
The five core aspects of the Omnibus rules include the following:
- Recent amendments, namely, the HITECH act
- The most recent structure of fines according to HITECH act
- The changed post-breach harm threshold and the Breach Notification Rule for Unsecured ePHI.
- Provisions by the Genetic Information Nondiscrimination Act (GINA)
- The ban to use PHI data for marketing purposes
Challenges in Implementing HIPAA Rules in Telemedicine
As healthcare providers increasingly turn to remote options, ensuring the security and privacy of patient information becomes paramount. Let’s delve into the hurdles when building HIPAA-compliant telehealth platforms.
Keeping Telehealth Sessions Safe
Cybersecurity threats are ever-evolving, necessitating continuous updates to maintain robust security protocols. Among the primary risks of telehealth meetings is the potential unauthorized access to video conferences or sensitive patient data. Implementing password protection, secure Wi-Fi networks, and encryption for both software and hardware is imperative to mitigate these risks.
Sharing Patient Information Safely
The transmission of sensitive patient information between healthcare providers poses another hurdle. While convenient, conventional methods like texting or private messaging may compromise HIPAA standards. Establishing strict communication protocols and educating patients on secure information transmission methods are vital to prevent unauthorized access to sensitive data.
Keeping Stored Data Secure
Patient data is vulnerable to security breaches through remote hacking or internal tampering. Healthcare professionals must employ stringent security measures, including regular software updates, employee training, and robust data management practices, to safeguard against data breaches.
Keeping Up with Privacy Laws
HIPAA serves as the cornerstone of patient privacy protection in the United States, but healthcare providers must remain vigilant of evolving data security regulations. Ongoing training and proactive compliance measures are essential to adapt to changing laws and regulations, ensuring comprehensive protection of patient information.
Adapting to New Technology
The dynamic nature of technology introduces opportunities and vulnerabilities in telemedicine platforms. Healthcare providers must stay updated on the latest hardware and software developments, ensuring proper implementation and integration with existing systems. Consultation with IT professionals may be necessary to optimize technology usage and enhance security measures.
The Most Typical HIPAA Infringements in Telemedicine
If you wonder how to start a telemedicine practice, learning from others’ experiences will help you avoid mistakes and shortcomings. For example, this infographic shows the most frequent extra measures that companies are taking to protect the privacy and integrity of their patients’ PHI.
Let’s now explore the examples of HIPAA violations in telemedicine platforms.
2023 HIPAA Penalty Structure
| Penalty Tier | Culpability | Minimum Penalty per Violation – InflationAdjusted | Max Penalty per Violation – Inflation Adjusted | Maximum Penalty Per Year (cap) – Inflation Adjusted |
| Tier 1 | Lack of Knowledge | $137 | $68,928 | $2,067,813 |
| Tier 2 | Reasonable Cause | $1,379 | $68,928 | $2,067,813 |
| Tier 3 | Willful Neglect | $13,785 | $68,928 | $2,067,813 |
| Tier 4 | Willful Neglect (not corrected within 30 days) | $68,928 | $2,067,813 | $2,067,813 |
EHR Breach
Electronic Health Records (EHR) contain all the sensitive data of healthcare clients, and are often subject to breaches. Failing to ensure a required level of network protection may result in unwanted exposure or loss of PHI during data processing.
The solution may lie in running regular risk assessments and penetration tests and utilizing data encryption. However, Routine vulnerability scans will reveal loopholes in your network security before the breach occurs. For instance, in 2018, UnityPoint Health was fined $2.8 million for an EHR breach that exposed the data of 1.4 million patients due to insufficient risk analysis and risk management processes.
Sending PHI to the Wrong Patient/Contact
Errors may occur with no evil intent. Human error is a frequent cause of HIPAA breaches when users’ privacy gets accidentally infringed.
To eliminate the risk of error, recipient verification can be integrated into your telemedicine platform to ensure secure data transmission. Also, it is crucial to educate all employees about data protection principles.
A real-world example highlighting the importance of proper handling and disposal of PHI is the case of Joseph Beck, a former dentist from Kokomo, Indiana. Beck failed to ensure the secure destruction of patient records, resulting in a breach of PHI.
Beck had hired a data company to destroy the paper records of his former dental patients securely. However, instead of properly disposing of the records, someone discarded 63 boxes containing approximately 7,000 files with sensitive PHI in a nearby church’s recycling dumpster. An investigation revealed that the files had been left in the dumpster for at least a week, potentially exposing the personal information of thousands of individuals.
The discarded records contained a wide range of sensitive data, including names, addresses, phone numbers, medical diagnoses, X-rays, dental information, Social Security numbers, and credit card numbers.
While there was no evidence of identity theft resulting from this incident, Beck’s negligence in ensuring the proper disposal of PHI led to a $12,000 fine from the Indiana Attorney General’s Office for violating HIPAA regulations.
Hacking
Unfortunately, ePHI is a frequent target of hacker attacks. Healthcare data has a special value since it has a long shelf-life and may be used to buy prescription drugs and sold at a high price on the dark web. Using firewall protection and AI-driven antiviral software may help detect suspicious activity and withstand hackers’ assaults.
According to a recent report, a single healthcare record can fetch up to $1,000 on the black market, making it a lucrative target for cybercriminals. A notable example is the 2015 Anthem Inc. cyberattack, where hackers gained access to the personal information of nearly 79 million individuals, including names, Social Security numbers, birth dates, and other sensitive data. This breach highlighted the vulnerability of healthcare organizations to sophisticated cyber attacks.
Using firewall protection and AI-driven antiviral software may help detect suspicious activity and withstand hackers’ assaults.
Ransomware Attack
Ransomware is malicious software that blocks files or an organization’s entire operating system, demanding either a monetary reward or full access to information. Ransomware attacks result in downtime, and the harm they inflict is financial and reputational.
Use reputable antivirus software with ransomware detection and removal capacities to eliminate vulnerabilities. An IBM report states that companies that have implemented security automation technology driven by AI and data analytics and technologies like virtual desktop infrastructure (VDI) are less prone to ransomware and hacker attacks.
Malware Incident
Malicious software may harm, destroy, or reveal PHI. The impact of such incidents can be extremely negative and undermine patients’ trust in telemedicine.
Expert antivirus and firewall protection will help you avoid malware contamination. Also, you should adopt rules and policies regulating your staff behavior online. Set your firewall to block pop-ups, limit file sharing, and discard unsolicited emails with attachments.
Privacy violations are taking a heavy toll on healthcare providers’ budgets. A number of data breaches of an unprecedented scale has been witnessed during the COVID-19 pandemic. Statista says the average cost of security violations has risen to $9.48 million in 2023.
However, these incidents may be minimal if you make telemedicine app HIPAA-compliant initially.
How to Develop a HIPAA-Compliant Telemedicine Software
Dealing with secure telemedicine app development involves taking all the necessary steps to make a telemedicine platform HIPAA-compliant. Here are some tips on setting you on the right track and developing a HIPAA-compliant telehealth platform.
Set Up Secure In-App Connection
A rule of thumb says: first and foremost, set up a secure connection. You can’t use Skype, Zoom, email, and other popular means of web communication for telemedicine, as they lack the necessary security features. For a secure solution, consider either building your secure in-app messaging or video-chat tools using end-to-end encryption or using a HIPAA-compliant solution by a third-party provider under a special security agreement (which typically comes at a fee). For example, telemedicine platforms like AmWell and Teladoc have built-in secure video conferencing and messaging features that meet HIPAA telehealth requirements.
Use Appropriate Data Storage
Your data and how you store it can enhance or weaken your app security. The main principle applies here: Do not store unnecessary or obsolete data that you no longer plan to use. Avoid storing data altogether unless you have to.
According to HIPAA guidelines, protected health information (PHI) should be retained for at least six years after the last date of service or encounter. Regularly deleting old files will free up the storage space and account for better data management. The correct workflow principles implemented in software on an architecture level can minimize unnecessary duplicates that can render your system vulnerable to hacker attacks.
Use Secure Data Encryption
Encryption is a cornerstone of medical data protection. Even if hackers capture sensitive personal data, they won’t be able to use it because a secure encryption mechanism renders it unreadable. The data should be encrypted during transmission, i.e. telemedicine video conferencing and message exchange. Also, it is always best to store data encrypted to reduce the theft risk. Major telemedicine companies like Amwell and Doxy.me use end-to-end encryption to protect data during transmission and storage.
Even though encryption requires additional infrastructure capacities and increased network workload during transmissions, ensuring the security of sensitive health data is worth the investment.
Admin Access Control
Set up clear data access policies indicating who and when may view, update, copy, or transmit patients’ data. Distinct user roles will reduce the number of app users with access to PHI to a reasonable minimum and help you avoid data breaches. Have an administrator manage and assign user roles. For example, in a telemedicine platform, administrators can restrict access to PHI only to healthcare providers, while patients can only view their medical records.
For instance, the admin creates user roles with varying PHI access levels, assigns roles to users based on job duties, defines PHI data access policies per role, monitors user activities via audit logs, manages emergency access overrides, terminates departed staff access, reviews/updates privileges periodically for compliance, and trains staff on proper PHI handling while restricting sensitive data access to minimum required.
User Authorization
Set up sophisticated user authentication routines to eliminate the possibility of unauthorized access. Have users confirm their identity by SMS and use complex passwords. You may also implement biometric authentication solutions recognizing the user’s voice, face, or fingerprint.
A study found that a biometric patient ID system was accurate over 80% of the time. This could help stop patient mix-ups and medical identity theft. It also makes it easier for healthcare workers to identify patients without manually guessing or typing in data.
Authorization Monitoring
A log file containing instances of every successful or failed authorization attempt can help you detect suspicious activity in patients’ accounts. Blocking an account after several failed login attempts and having users confirm their identity may not appear user-friendly but will protect user accounts from hijacking.
Data Backup
Yes, you still have to back up some patients’ sensitive data, although it may contradict the Proper Storage principle. Have a security policy in place, indicating which of the patients’ information you may safely back up. Note that it is only safe to have duplicates of the least vulnerable data. According to HIPAA guidelines, backups of PHI should be encrypted and stored securely, with access limited to authorized personnel only.
Automatic Log Off
Forgetting to log off may allow hackers to access the user’s account. Have your telemedicine software log off automatically after some time of inactivity. For example, if a user remains idle for two minutes, the software automatically logs off, following best practices for securing healthcare applications.
Secure Documentation Management
A secure documentation management system will facilitate your document flow, help you manage user roles, and protect patients’ PHI from breaches and hijacks. It should include access controls, audit trails, and encryption to ensure the confidentiality and integrity of sensitive medical records.
Appointing Compliance, Privacy, and Security Officers
Having someone take individual responsibility for meeting HIPAA standards will maximize the efficiency of your security efforts. This is also a requirement of the federal HIPAA law and will help you ensure compliance. The designated HIPAA compliance officer should develop and implement policies and procedures to safeguard PHI and oversee regular risk assessments and employee training.
Personnel Training
Offer personnel training options for healthcare entities using your telemedicine platform. Educate their staff about the principles of secure data sharing, tips on how to avoid accidental disclosure, and best practices for handling PHI. Regular training is crucial for maintaining HIPAA compliance and preventing data breaches.
Regular Self-Audits
Running regular self-inspections will help you identify weak spots in your security protection before it’s too late and help you prepare for HIPAA audits. As surveys have revealed, the most difficult parts of preparing for audits are understanding the HIPAA requirements and ensuring the technology’s compliance. Learning from the industry’s best practices and staying at the forefront of all changes in healthcare security legislation is crucial to a successful HIPAA compliance program.
Our Experience of Developing HIPAA Compliant Telemedicine Software
At Empeek, we have acquired hands-on experience in implementing the HIPAA Privacy and Security rules.
By creating a HIPAA-compliant wireless medical monitoring system for our customers, we secure patients’ data and eliminate the risk of violation.
One of our latest projects is a cross-platform telehealth solution for Android and iOS, securely connecting patients and families with caregivers and physicians regardless of their physical location. The platform is packed with an extensive toolset enabling patients and doctors to hold remote consultations, schedule appointments, and much more.
Another project involved integrating EHR and telehealth when helping a US hospital reach more patients by replacing their legacy software with an end-to-end modern digital platform. The legacy system was desktop-based, and we had to upgrade the UI, user authentication, and workflow. We also automated routine processes like billing, appointment scheduling, and HIPAA-compliance activities.
We are also proud to share another project with you: the end-to-end development of a remote cardiac monitoring system. This involved developing a mobile cardiac telemetry system consisting of an ECG patch and a mobile app. The system is designed to monitor the cardiac health indicators of thousands of patients in real-time. Empeek developed a cloud-based solution with web and mobile applications, enabling real-time data processing, analysis, and transmission. The system tracks various cardiac health parameters, including ECG, heart rate, SpO2, temperature, and activity level. The project also involved consultation with FDA experts to ensure compliance with regulations.
And last but not least is the HIPAA-compliant telehealth platform for behavioral health. In this project, Empeek built an EHR system for behavioral health, along with iOS and Android mobile apps. The system helps patients reduce stress and anxiety by completing specially created surveys, setting up appointments with doctors, tracking weekly achievements, and receiving rewards. The solution includes a sophisticated questionnaire system, patient management, extended reporting, and gamification features. Empeek ensured the development of a HIPAA-compliant application to manage and store patients’ data securely.
Conclusion
In summary, HIPAA and telemedicine are crucial for keeping patient information safe. HIPAA rules set standards for protecting patient data in telehealth, and platforms need to follow these rules to keep electronic health information secure.
HIPAA-compliant platforms must adhere to rigorous standards outlined in the HIPAA Privacy Rule, Security Rule, Enforcement Rule, Breach Notification Rule, and Omnibus Rule. These regulations mandate robust protocols for data encryption, access control, and breach response, ensuring electronic protected health information protection in telemedicine settings.
Developing HIPAA-compliant telemedicine software necessitates a comprehensive approach encompassing secure communication, encryption, user authentication, and regular audits. By appointing compliance officers, providing staff training, and leveraging advanced technologies, healthcare providers can navigate challenges such as cybersecurity threats and evolving privacy laws.
Ultimately, prioritizing HIPAA compliance in telemedicine development is essential for fostering patient trust and enabling transformative healthcare delivery. By aligning with the principles of HIPAA and telemedicine, stakeholders can navigate regulatory complexities while advancing patient-centric care in the digital age.
At Empeek, we know what it takes to develop HIPAA-compliant platforms. We are ready to guide you through the intricacies of safeguarding patients’ sensitive data and offering a HIPAA-compliant telemedicine software development solution. Schedule a talk with our development experts right now, and we will help you bring your telehealth app idea to life.
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