Health Insurance Portability and Accountability Act (HIPAA) is meant to create and uphold the standards for protecting, handling, and disclosing sensitive patient data. The violation of HIPAA rules can lead to considerable financial and reputational losses for healthcare organizations. That makes HIPAA-compliant healthcare software development paramount in today’s digitized healthcare industry.
As defined by the HIPAA Journal, a violation is when a HIPAA-covered entity – or business and technology affiliate – fails to comply with one or several provisions of the Security, Privacy, or Breach Notification rules. The bad news here is that there are many ways to violate the Rules, but the good news is that a reliable healthcare software development partner can help you prevent most types of violations. So let us see the most common examples of unintentional HIPAA violations and how you can avoid them with the help of an expert vendor.
The Role of HIPAA-Compliant Software in Modern Healthcare
With the rising importance of digital tools in delivering healthcare services, ever-increasing amounts of patient data get subjected to security risks. The times when doctors had to fill out the patient data by hand and store them on paper cards were nearly gone, and most of the patient data was digitized.
With the advent of the Electronic Medical Record (EMR), it has become much easier for doctors to fill the patient cards, share them with other healthcare practitioners, update, navigate, and use the data. However, there has also been a surge in data breach incidents leading to the theft or loss of patient records.
The emergence of the Internet truly changed medical record-keeping practices, making them more convenient, but it has also increased security risks. Thus, HIPAA compliance becomes crucial. It changes how technology companies organize the healthcare development process and approach the mHealth data storage security problem.
HIPAA regulates healthcare organizations’ data security standards and protects patient information from being compromised, stolen, or unlawfully used. Failure to comply with the Rules can result in severe fines, loss of license, and even jail time. So it is in any healthcare organization’s best interest to follow the rules.
The Threat of Compliance Breach and Possible Outcomes
Many types of violations differ in severity, which naturally determines the fine. In 2022, it can range from $127 to $1,9 million. This year’s average penalty has reached $117,184 per case, which is a considerable amount of money for most healthcare organizations.
Of course, HIPAA does not require to fine everybody. Each separate case is subject to investigation, and sometimes, clinics get away without a fine. Organizations often do not violate HIPAA intentionally or fall victim to hacker attacks. If due diligence has been preserved and the organization reported the violation, HIPAA would often omit fines.
Tiers of Violation
HIPAA defines four tiers of violation:
- Tier 1: The organization violates the Rules unknowingly or unwillingly and takes reasonable effort to prevent the violation or mitigate its outcomes.
- Tier 2: The organization knowingly violates the Rules but cannot prevent the violation even with reasonable effort.
- Tier 3: The organization willfully neglects the Rules but attempts to make corrections.
- Tier 4: The organization willfully neglects the Rules and makes no effort to correct the violation.
The violation’s potential outcomes for healthcare organizations may vary depending on the tier.
A more severe outcome is criminal penalties that are especially threatening for healthcare practitioners who either disregard the Rules or abuse their access to patient information:
- Tier 1: Reasonable cause for violation or lack of knowledge – up to 1 year in jail;
- Tier 2: Obtaining patient information under false pretenses – up to 5 years in jail;
- Tier 3: Obtaining patient information with malicious intent or for personal gain – up to 10 years in jail.
Loss of license, civil penalties, and reputational damage are the other outcomes of HIPAA violation. And that is precisely why healthcare organizations need to use secure mHealth data storage, have access control, and work with reliable providers of healthcare software services.
10 Common HIPAA Violations in Clinical Environment
What are the most common examples of unintentional HIPAA violations in the clinical environment, and how do they happen? As mentioned, there are many ways a healthcare practitioner or organization may violate HIPAA compliance, so let us look at some of the most widespread.
Snooping of Patient Records by Relatives or Friends
The disclosure of patient data violates the Rules, even regarding patients’ close relatives and friends. Of course, that rule can be modified when patients cannot make decisions for themselves. But when they can assess their situation and make decisions independently, the data cannot be presented to anyone except them and authorized healthcare practitioners.
Failure to Assess Risks
Risk assessment is the basis for preventing any potential data breaches. Failure to properly assess the risks related to the security of EMR and patient data is a form of due diligence breach. That can result in considerable fines for the organization.
Lack of Proper Risk Management
Failure to establish and maintain effective risk management practices within healthcare organizations is the logical continuation of the previous issue. Not being able to assess risks means the organization cannot prepare for those risks either.
Denying or Delaying Data Access for Patients
Patients have the right to timely access to their data. Any delays or willful denial of data for the patient is a direct violation of HIPAA and can result in hefty fines.
Not Entering a HIPAA-Compliant Business Associate Agreement
If you decide to work with any business or technology partner and share patient data, you must ensure they are also HIPAA-compliant. Thus, HIPAA-compliant healthcare software development is only possible with a vendor who follows these standards.
Insufficient Control over Electronic Patient Health Information (ePHI) Access
Depending on their role and responsibility, clinical staff must have different access levels to patient data. That is why you need your healthcare software development partner to set up access control features to limit the personnel’s capabilities. Failure to introduce these features may result in data breaches and loss of sensitive information, which will cause fines.
Lack of Encryption on Portable Devices
With the ubiquitous use of portable devices such as tablets and smartphones in clinics comes the need for proper encryption and safeguarding of the ePHI. Encryption is not mandatory under HIPAA, but any portable device must have some adequate means for data protection.
Exceeding the Breach Notification Deadline
One better way to reduce the penalty’s size is to report the data breach. Depending on the breach severity and the number of affected patients, an organization has 30-60 days to report it. Failure to comply with the deadline leads to more severe fines.
Unauthorized Disclosure of PHI
Impermissible disclosure of patient data to third parties outside healthcare organizations can lead to significant penalties. Proper security protocols, encryption, access control, and the use of secure mHealth data storage are necessary, and you need an expert provider of healthcare software services that can guarantee that.
Improper Disposal of PHI
Any data that is no longer useful or relevant must be disposed of properly. Any electronic data or devices storing it must be deleted or destroyed, and you must also shred all paper records.
These are some of the most common mistakes healthcare organizations make, either through a lack of knowledge or due diligence. However, there are many more ways in which they might accidentally breach HIPAA compliance. Some of such issues are related to improper employee training rather than the technical inefficiency of your medical software. But some problems come from poor management, outdated technology, or poor data handling methods.
How to Avoid HIPAA Violations via Software Development Partnership
HIPAA compliance starts with proper employee training. But reliable and secure healthcare software will do most of the heavy lifting here. You will need a strong partner who can:
- Develop HIPAA-compliant systems
- Improve the performance of your clinical staff
- Maintain the security of mHealth data storage
Thus, your HIPAA-compliant application must be developed by a reliable vendor with the technical expertise and mature development practices to ensure adherence to the standards.
There are eight essential items on the HIPAA compliance checklist any provider of healthcare software services needs to keep in mind when approaching your project:
The right people must have access to the right data. Only healthcare practitioners with the proper access levels have to be able to deal with patient data or separate data sets. Two-factor authentication is a must for keeping the data safe and preventing unauthorized access.
Patient Data Encryption
It would help if you protected all the ePHI using the appropriate encryption methods, such as AES 256-bit and S/MIME. Encryption keys of sufficient length must be used whenever it comes to sensitive patient data, and 256-bit keys are used in healthcare, finance, and even military sectors as they are nearly impossible to breach.
Proper audit mechanisms allow you to track the access and utilization of the application by the users. Thus, you can see whether suspicious activities have occurred within the system and whether any data has been compromised. It would help you respond quickly to the threats and identify the culprits.
Each data entry or manipulation has to be authorized. Blockchain technology is frequently used to ensure proper authorization of the users. Having patient data manipulated by unauthorized users is a clear violation of HIPAA, and you need to ensure that does not happen.
Safe Data Transfer
Using secure data transfer connections and protocols like SSL/TLS is one of the keys to avoiding HIPAA compliance violations.
Push notifications can be an unexpected route for data breaches. It is essential to separate patient data from the notification so that it never shows in emails or other outside-the-app communication.
Data backups are vital for preventing the heavy outcomes of HIPAA violations. Even if data gets compromised, you can restore or remove the PHI from other devices to prevent further harm. Then, you can report an unintentional HIPAA violation to prevent considerable fines.
Naturally, there is more to HIPAA compliance, and you must consider employee training as the priority apart from partnering with a reliable healthcare software development company. After all, there are many careless mistakes that can lead to a breach of HIPAA compliance, such as:
- Using personal emails to share patient data
- Leaving portable devices unattended
- Not using secure passwords
- Divulging information during personal conversations
That is why it is also critical to introduce the HIPAA culture within healthcare organizations.
Bottom Line: The Key to HIPAA-Compliant Healthcare Software
You need to understand that it is impossible to guarantee 100% protection from HIPAA violations. There always is a chance that hackers will successfully breach your firewalls or that one of your employees will get careless and accidentally disclose some data. What you need to do is to make all the necessary efforts to prevent that from happening.
When it comes to HIPAA-compliant software healthcare software development, you must take all the steps to ensure adherence to the rules. A reliable healthcare software partner like SPsoft can help you take those steps and guide you through that journey. Use our experience building HIPAA-compliant healthcare software and avoid the steep price of breaking the rules.