The telemedicine solutions market share is set to reach $ 559.52 billion in 2027, expanding at a CAGR of 25.5%. The stage for its growth is set by the pandemic crisis, healthcare accessibility issues, and the demand for safe and fast medical services.
However, telemedicine app development has a number of nuances that companies must take into account, and compliance with the Healthcare Insurance Portability and Accountability Act (HIPAA) is one of them.
The companies willing to tap into telemedicine app development have to build their solutions in accordance with the Health Insurance Portability and Accountability Act (HIPAA). In this article, we will provide some insights on how to make a HIPAA compliant telemedicine software and what aspects need to be considered throughout the development and implementation.
Ready to explore the specifics of building a HIPAA compliant telemedicine software? Let’s start with outlining the core HIPAA standards.
HIPAA Guidelines for Telemedicine Platforms
Signed by President Bill Clinton back in 1996, HIPAA aims to protect the patients’ sensitive medical data by regulating its processing and exchange methods.
All HIPAA rules are mandatory, and HIPAA-covered entities are penalized for non-compliance. The fines for HIPAA infringements are no trifle and may reach up to $1.5 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 basic HIPAA facets that are further described below.
The HIPAA Privacy Rule
The HIPAA Privacy Rule obliges all medical organizations to stand on guard of the privacy of their clients’ personal health information (PHI). Telehealth 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”
For more information about this and other HIPAA rules, check out The US Department of Health and Human Services.
The HIPAA Security Rule
According to the HIPAA Security Rule, a digital system or an individual that has access rights to patients’ data should be responsible for its security. Providers of medical services have to put in place 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 datacenter, 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 aimed at risk assessment and identifying 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 an intent or not. The detailed overview of compensation policies is provided below.
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 take into account all the established policies and comply with them.
The Breach Notification Rule
The Breach Notification Rule explains the procedure that needs to be followed during data leakage. As 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 also has to reveal the situation to the media, in case a breach has negatively impacted more than 500 patients. If the privacy of less than 500 patients was affected, a healthcare company is obliged to inform an OCR portal.
The Omnibus Rule
Created in 2013, 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 are also obliged to comply with HIPAA. There are a number of challenges related to HIPAA Omnibus Rule. Let’s view them below.
The Omnibus Rule introduces the umbrella term ‘Business Associates’ applying to all parties that may access PHI during their cooperation 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
The Most Typical HIPAA Infringements in Telemedicine
If you aim at implementing a HIPAA compliant telehealth platform, learning from others’ experience will help you avoid mistakes and shortcomings. For example, the infographic below 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.
Electronic Health Records (EHRs) contain all the sensitive data of healthcare clients and therefore 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, as well as in utilizing data encryption. Routine vulnerability scans can also reveal loopholes in your network security before the breach takes place.
Learn more about how to mitigate security risks in EHR development in our recent article.
Sending PHI to the wrong patient/contact
Errors may occur through 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 the principles of data protection.
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 the assaults of hackers.
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 both financial and reputational.
To eliminate vulnerabilities, use reputable antivirus software with ransomware detection and removal capacities. An IBM report states that companies that have implemented security automation technology driven by AI and data analytics, as well as technologies like virtual desktop infrastructure (VDI) are less prone to ransomware and hacker attacks.
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 on the web. 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 have been witnessed during the COVID-19 pandemic. According to the IBM report, the average cost of security violations has risen to $7.1 million in 2020.
However, these incidents may be reduced to a minimum if you make the telemedicine app HIPAA compliant at the very beginning.
How to Develop a HIPAA Compliant Telemedicine Software
Building a secure telemedicine platform involves taking all the necessary steps to make a telemedicine platform HIPAA compliant. Here are some tips on how to set you on the right track and develop a telemedicine platform HIPAA compliant.
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. If you’re looking how to develop HIPAA compliant telemedicine software, consider two options: either building your own secure in-app messaging or video-chat tools or using a solution by a third-party provider under a special security agreement (comes at a fee, though).
Use Appropriate Data Storage
The data you store and the way you store it can actually enhance or weaken your app security. The main principle that applies here – do not store unnecessary or obsolete data that you no longer plan to use. Avoid storing data altogether, unless you absolutely have to.
Developing a habit of deleting old files will free up the storage space and account for better data management. The right workflow principles implemented in software on an architecture level can actually 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. every video-conferencing and message exchange. Also, it is always best to store data encrypted to reduce the risk of theft.
Even though encryption requires additional infrastructure capacities and increased network workload during transmissions, it is worth the investments.
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 that have access to PHI to a reasonable minimum and help you avoid data breaches. Have an administrator manage and assign user roles.
Eliminate the possibilities for unauthorized access by setting up sophisticated user authentication routines. 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 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 particularly user-friendly, but will protect user accounts from hijacking.
Yes, you still have to back up some of the 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.
Automatic Log off
Forgetting to log off may actually open hackers a doorway into 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.
Secure Documentation Management
Implementing a secure documentation management system will not only facilitate your document flow, but also help you manage user roles and protect patients’ PHI from breaches and hijacks.
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 one of the requirements of the HIPAA law and will help you ensure compliance.
Offer personnel training options for healthcare entities that will be using your telemedicine platform. Educate their staff about the principles of secure data sharing, tips on how to avoid accidental disclosure, etc.
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 survey results below demonstrate, the most difficult parts of preparing for audits are technical and administrative safeguards.
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.
Real-Life Use Cases of HIPAA compliant software development
At Empeek we have acquired hands-on experience in putting the HIPAA Privacy and Security rules into action. By creating HIPAA compliant telemedicine apps 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 Empeek’s project involved integrating EHR and telehealth modules on a single platform to help a US hospital better manage its patients. By replacing their legacy software with an end-to-end modern digital platform, Empeek was able to automate some of the routine processes such as billing, appointment scheduling, and HIPAA-compliance activities.
HIPAA compliance in telemedicine applications is paramount to helping healthcare practitioners maintain trusting relationships with their clients. However, building a platform that complies with all HIPAA standards may be challenging, especially if you have no in-house expertise in developing healthtech applications. Apart from encryption, authentication and secure data storage, your solution will need robust data-driven security protection.
At Empeek we know all it takes to develop a HIPAA compliant telemedicine software, and we are ready to guide you through all the intricacies of safeguarding patients’ sensitive data. Schedule a talk with our development experts right now and we will help you bring your telehealth app idea to life.