The last few years will go down in history as a period of increased awareness of well-being. Mobile apps, in particular, have empowered users with on-the-go opportunities to manage their health. Fitness apps, telemedicine solutions, and other well-being applications have acquired a growing user base that further contributes to digital health’s market growth.
In 2022, the mHealth industry is set to score a new record after its market size stood at $38.2 billion in 2021. During the forecast period of 2022 to 2030, it is expected to expand at a CAGR of 11.8%. The growing popularity of fitness and medical apps, as well as an increasing smartphone adoption rate among patients, are projected to further contribute to the field. Digital health is, however, subject to stringent regulations that guard users’ data privacy.
The Health Insurance Portability and Accountability Act (known as HIPAA) is what safeguards private and sensitive patient data, thus making HIPAA compliance crucial for mobile applications. In this post, we’ll lay out the nuts and bolts of HIPAA compliance for your health app and see whether you need it at all.
What Is HIPAA Compliance?
HIPAA compliance refers to the set of federal laws that establish rules for sharing personal medical information and protecting it from unauthorized use. In simple terms, the provision prohibits access to personal health information without the explicit consent of the holder.
Any violation of this law is liable to enormous fines. Penalties up to $25K can be issued per violation category, per calendar year. All fines apply to mobile healthcare applications, which makes complying with HIPAA requirements even more important.
The main concepts of the HIPAA guidelines include the following:
- Protected health information (PHI): any personal information about the patient or data about their health state that is held by a medical provider. PHI may include everything from names to lab tests.
- Covered entities: healthcare participants that get hold of PHI. These may include clinics, doctors, insurers, and others.
- Business associates: contractors that provide services to a healthcare provider in which PHI is disclosed.
Therefore, if your medical application falls into one of the last two categories, it makes compliance with HIPAA mandatory. However, not all healthcare app owners have to abide by the act. Some app categories can get away with general security measures.
What Mobile Health Apps Need To Be HIPAA Compliant?
According to a study, 88% of mHealth apps include code that can potentially disclose sensitive patient information. This means that the backend of the application exposes PHI to additional risks and may compromise users’ security and privacy. In the HIPAA arena, the majority of those apps would face serious repercussions.
So, how do you know whether you need compliance with HIPAA? Here are the main criteria.
Your app’s target audience
If your mobile solution caters to a covered entity (e.g., telemedicine or hospital apps), your application should be covered by the act. Business associates that have wide access to sensitive data, as well as third-party vendors, also assume liability for any regulation violations.
However, the compliance guidelines do not apply to your app if it doesn’t allow for data sharing. Different types of tracker apps, for example, can collect PHI but neither make the user identifiable nor share the data with anyone.
Your data type
As we mentioned earlier, the act promotes PHI protection. Therefore, if your mHealth app collects, processes, and shares any identifiable information, HIPAA guidelines are compulsory for the development process.
However, the HIPAA Privacy Rule states allowable uses of protected health information that do not require mandatory compliance. Thus, if your medical app allows PHI sharing for treatment purposes or provides access to healthcare operations, the PHI guidelines do not affect your solution.
Your hiring company
If you are an app vendor or developer that is not considered a covered entity, you can still be classified as a business associate. Therefore, if the healthcare provider contracts with you for PHI-related services, you need to comply with the act. Thus, if you are creating, receiving, updating, and sharing protected health information on behalf of a covered entity, your application must abide by the guidelines.
What Type of Patient Data Is HIPAA?
The legislation obliges all related parties to treat personally identifiable information as protected health information. Any health information that provides insights into the past, present and future health state of the user is ranked as PHI. Even driver’s license numbers or birth dates can potentially give away the identity of the patient and are covered, provided they are linked with health information.
However, if your application processes PHI with no identifiers, it ceases to be covered by the HIPAA Privacy Rule’s restrictions.
According to HIPAA Journal, the following 18 identifiers make your health information PHI:
However, if a user uses the application to monitor vitals such as body mass index (BMI) or heart rate and the collected data is not sent to the key participants of the HIPAA framework, this type of data is not bound by the act’s requirements.
Key Elements of HIPAA
The HIPAA compliance checklist rests on five core blocks that specify US standards for aggregating, exchanging, storing, and using protected health information. Thus, the following five directives are the bedrock of the regulation.
The overriding objective of this block is to safeguard PHI collected or transmitted by a covered entity or its business associate. This law applies to all types of covered entities and applies to protected data sent in any form, be it electronic, oral, or paper. The rule doesn’t prohibit using or disclosing PHI as long as it meets the Privacy Rule.
Medical applications that handle PHI data must abide by the following requirements:
- Obtain the user's permission before using or disclosing PHI for all purposes, except for treatment, payment, or health care operations.
- Clearly inform users about the cases, methods of use, and disclosure of data.
- Introduce limited access to data.
- Impose limitations on data uses and disclosures.
- Grant users access to their own PHI.
- Make sure users can limit the usage or disclosure of protected information.
This building block of the legislation prioritizes the protection of electronically managed PHI. To prevent data misuse or leaking, the parties involved must set up technical and non-technical protection measures. These are meant to guarantee the confidentiality, integrity, and security of sensitive information.
In practice, this type of rule necessitates app developers to set up authorized access and encrypt data. The Security Rule can also be implemented through rigorous vulnerability assessment and other preventive measures such as access protocols, backups, audit controls, and access logs.
Breach Notification Rule
The Breach Notification Rule is a federal law that requires organizations to notify individuals if their personally identifiable information has been compromised as a result of a data breach. The organization has 60 days to provide the notification. The party must advise the patient or user on any steps needed to protect the compromised data.
Moreover, a HIPAA violator has to follow one of two protocols that describe the number of people affected. The two also differ in the notification period regarding the data leak.
The Enforcement Rule comes into force when protected information is violated. It establishes provisions for holding associates and providers accountable for the breach or misuse. The investigation process is initiated when an affected side makes a complaint.
According to the enforcement results, the HHS Office for Civil Rights has received over 259K HIPAA-related complaints since 2003. Of these, 256,086 complaints have been resolved or solved, which reinforces the importance of compliance for any type of application.
Patient Safety Rule
Although it doesn’t tie into any technical measures, the Patient Safety Rule is an indispensable part of compliance. Under the auspices of the Patient Safety Act, healthcare providers may voluntarily provide valuable patient data to Patient Safety Organizations. The rule intends to analyze and gather information on patient safety events instead of being an error-reporting framework. As for app developers, the act doesn’t force any technical limitations or safety nets.
Common HIPAA Compliance Pitfalls to Avoid
In 2019, a bunch of HIPAA violations resulted in hefty penalties for Jackson Health System. The Florida-based nonprofit academic medical system settled its HIPAA case with a $2.15 million civil monetary fine. To avoid similar monetary and reputational risks, owners and publishers of medical-related software should be aware of common HIPAA violations.
Below, you will find some of the widespread ones that haunt app developers as well.
HIPAA infringements can creep their way into the system through multiple internal leaks or incidents. In most cases, violations are unintentional, yet this doesn’t mitigate the aftermath. Most of these risks can be prevented through data encryption, proper security standards, and access controls. Thus, even if your smartphone ends up in the wrong hands, the device owner is not liable for penalties, provided the data is encrypted from the public eye.
HIPAA Compliance Amidst the Pandemic
Besides adverse public impact, COVID-19 also takes a toll on the privacy and security of medical information. In particular, the outbreak sparked an upswing in medical data breaches. These reached an all-time high in 2021, impacting around 45 million people. Therefore, the official HIPAA security rule checklist has never been more relevant.
Telemedicine and remote medical services have also had an unfortunate effect on security coherence. However, telehealth has acquired a new regulatory status during the pandemic and is not subject to any HIPAA penalties for the time being. Nevertheless, the adoption of telemedicine solutions reinforced the importance of multidevice compliance and PHI security.
Related: How to Develop a Telemedicine App: Trends, Features and Costs
To avoid PHI leakages, providers should follow telehealth security safeguards that will ensure remote data immutability while offering offline-like access to data. Data encryption, access control, and security audits should be paid due diligence when building an on-demand application. Moreover, organizations should establish a system of monitoring communications containing ePHI to avert accidental breaches.
How To Build a HIPAA-Compliant Mobile Application
HIPAA compliance can turn out to be an uphill battle for mHealth app owners. Multiple requirements, stringent regulations, and significant penalties can also send chills up their spines. HIPAA-compliant app builders aim to ease the strain on medical app owners by offering ready-made security solutions. Yet, you have to be aware of all nuances to keep your application penalty-free.
As we’ve mentioned, HIPAA requirements fall into non-technical and technical ones. While the former are easier to score, technical compliance requires more expertise. Risk analysis, data encryption, and PHI disposal rules are just a sliver of all the necessities. So, which of the following is required by HIPAA standards? Let’s see.
Making your data unreadable to third parties is the first and foremost step towards compliance. It is a requirement under HIPAA to prevent unauthorized access to apps that translate sensitive data into another form. In the case of theft or leakage, the encrypted data will stay unreadable without the correct encryption key. This security method keeps patient information safe and sound both in the cloud and on premises. When your data is sent across a network, additional in-transit certificates are necessary to encode the information.
Access control is listed among the first technical safeguard standards in HIPAA. Access restrictions limit the network participants who have access to critical information. When properly implemented, access controls reduce the danger of information being viewed without authorization and minimize the possibility of a data breach.
In simple terms, healthcare providers aren’t allowed to give access to users or software applications without authorized access rights. This reinforces the Minimum Necessary Standard, which holds that no one should see more patient data than required to carry out their responsibilities.
From a technical perspective, the Access Control standard presupposes:
- unique user identification system (biometric access, smart keys, password, or PIN),
- emergency access procedures (offsite backups, response alarm procedures),
- automatic logoff, and
- comprehensive data encryption and decryption.
A thorough HIPAA security risk analysis is another crucial enabler of data security. Security audits usually rely on a set of internal or external criteria regulating compliance with HIPAA. Beside compliance checks, auditors also perform risk assessment, vulnerability assessment, and penetration testing. Security analysis should be performed continuously, thus ensuring systematic security evaluation of evolving medical systems and data.
Proper disposal methods
While paper records can be shredded or burned, electronic patient information cannot be made unreadable through traditional disposal methods. According to the HIPAA Privacy and Security Rules, the final disposition of ePHI and its media may be carried out through clearing or purging. If the electronic media must be destroyed before disposal, methods of destruction may include dissolving, crushing, melting, incinerating, or shredding the medium.
Finally, HIPAA-compliant backup systems are a must for any PHI-bearing software. Typically, businesses adhere to a cloud backup strategy since it’s easier to implement. In this case, app owners can recover data at any time and place, provided they have an Internet connection.
Alternatively, organizations may rely on a hybrid backup solution that includes on-premises servers and cloud storage. In any case, the backup solution must be protected by encryption and factor in data redundancy, restoration, and monitoring activities.
Hiring a HIPAA-experienced vendor is the final and most important measure to make your app HIPAA compliant. Along with a standard NDA and other administrative precautions, you need to sign a Business Associate Agreement, or BAA, with your vendor before sharing any sensitive patient data. A BAA creates a bond of liability between a subcontractor and a covered entity or business associate, as well as guarantees the safety of PHI.
However, a BAA doesn’t guarantee the compliance of your app with the regulation. That is why app owners often resort to third-party HIPAA-compliance testing post-production and perform a security risk assessment of an operating application.
The Road to HIPAA Compliance on Mobile
Healthcare mobile applications are a game-changing medical innovation that facilitates remote care and improves patient outcomes. The majority of mHealth solutions are designed to build a bridge of trust between doctors and patients, thus transmitting sensitive and health-critical information.
Leaked personally identifiable information, in turn, poses a potential threat to both parties and is subject to HIPAA regulation. Stringent HIPAA guidelines are challenging yet mandatory to follow if you’re building a mobile healthcare application. They ensure the technical integrity of your medical tech system and prevent PHI from being misused.
If you’re seeking HIPAA expertise for your mobile application, Orangesoft experts are always ready to make your mobile solution HIPAA compliant. Contact our team for more information on HIPAA-compliant application development.