Numerous cyber threats against private healthcare data may arise unless health records are protected according to HIPAA. It’s a strong word, isn’t it? Does software security need to be supported by federal law?
The actual practice suggests that HIPAA compliance is a must for any healthcare-related software system that deserves having people’s trust. The HIPAA law has a decades-long history to impact software developers. HIPAA violation leads to any non-compliant healthcare application losing its value in the eyes of both patients and healthcare authorities.
“To be compliant or not to be” is not the question, therefore. How to comply with HIPAA explicitly is what software developers should know to stay competitive in the healthcare market.
Let’s discover what HIPAA regulations imply as well as how to create HIPAA compliant healthcare software.
What Is HIPAA?
Imagine one of your family members appears in a hospital or the E.R. When you are trying to learn your relative’s condition, a doctor or nurse shrugs saying that they “may not get into details not to violate HIPAA”. That’s not exactly true unless it comes to a certain health record. Anyhow, it is better to know what HIPAA is and how to deal with the regulation.
Health Insurance Portability and Accountability Act (HIPAA) is a federal law that has been regulating privacy in health records since 1996. To put it simply, HIPAA stands for making rules in exchanging personal medical info as well as protecting the info from unauthorized access.
The HIPAA law is applied to data collection carried out at hospitals, doctor offices, and other medical institutions where healthcare services are provided. Besides, the HIPAA law applies to commercial enterprises that assist healthcare providers in data management and storage. Since data carriers can be both physical (paper) and digital (software), any sort of health record can be subject to HIPAA law.
The regulation allows both direct caregivers and the ones who pay for healthcare services to get access to the private data covered with the law. Employers, marketers, fundraisers, and other individuals who do not meet the above-mentioned categories cannot see the data.
Check out this video
What Do HIPAA Security Rules Rely On?
The HIPAA law is based on the two key ideas about the care of patients:
Inviolability of private life. This is about the human rights that put certain limits on what anyone may know regarding the medical conditions of people. It also includes restrictions on places where healthcare details are discussed in front of other people.
Privacy. This is about the responsibilities of medical staff to disclose private medical info of patients only with their consent unless it is either required by law or necessary for clinical reasons.
Who Can Have Access to Medical Data According to HIPAA?
This issue is too sensitive to be left without corresponding regulation. It is taken for granted that doctors get primary access to the medical data of patients. To whom doctors may disclose that info is just the question the HIPAA law addresses.
The caregivers, nurses, close relatives, and some other categories of people can potentially be informed about the patient's conditions by doctors. At the same time, the HIPAA regulations require doctors to respect the views of their patients if they can say no. Besides, HIPAA makes all healthcare providers apply professional judgment to the medical data they can freely exchange.
But if patients argue against providing access to their data, nobody has the right to violate such prohibition following HIPAA. Hence, the following categories determine those who remain relatively independent in receiving and processing patients’ data as HIPAA stands:
Doctors may share the patients’ data with nurses, caregivers, therapists, and other medical specs who directly participate in the treatment.
Various healthcare providers when they have to make certain decisions instead of patients in the unconscious state. They must apply professional judgments while deciding with which audiences the confidential data can be shared.
Health insurance agents, officers of various federal entities, and other specs engaged in the treatment coordination. This category can include software vendors who create software for health records, hospital management, and other healthcare domains.
How to Interpret the HIPAA Minimum Necessary Standard?
Assume you are developing a software solution for a healthcare service provider. The organization will communicate with various partners, patients, and contractors via your solution. The software must be HIPAA-compliant by default. The audience will include the two following categories of recipients: healthcare professionals explicitly covered by the HIPAA law, and other people whose status is not so clear concerning HIPAA regulations.
There is the so-called HIPAA minimum necessary standard that has been specifically designed to apply to the second category. However, it is crucial to correctly interpret the standard for the right separation of church and state.
The standard requires all covered entities to make “reasonable efforts” to provide minimum possible access to protected health information (PHI) while it has to be disclosed or shared. Quite a vague definition, isn't it? To confuse neither situations nor personalities concerning the HIPAA minimum necessary standard, we propose to see when the standard appears to be redundant.
When PHI is requested by a professional healthcare provider for treatment.
When PHI is requested by an individual to whom the dataset concerns personally.
When PHI can be accessed via a secure authorization procedure.
When the Department of Health and Human Services (HHS) requires PHI for making changes in the rules.
When PHI is requested by legal entities under criminal law.
The variety of other circumstances requires making reasonable decisions to whom and for which purpose PHI can be disclosed.
Who Does HIPAA Apply To
How broad can be a list of the companies and organizations that have to comply with the HIPAA law? Unlikely this is an idle question for software developers whose professional competence allows building HIPAA-compliant applications. Moreover, sometimes customers require certain assistance in understanding whether their projects can accidentally violate any of HIPAA security rules.
All entities covered by the HIPAA act can be divided into two big categories:
Medical specs when they are directly involved in patients’ data processing during caregiving and treatment. This category includes various healthcare service providers besides doctors, nurses, clinics, and pharmacies. They are national healthcare programs, health insurance companies, and various healthcare management entities. Besides, such organizations as clearinghouses and billing services that provide data exchange between the community and all above-mentioned entities belong to this category.
Business entities that collaborate with the ones listed in the previous category. Such third-party companies execute certain activities on behalf of the organizations covered with the HIPAA rules directly. This category is too broad to be precisely described. Some examples of the entities include the following to name a few: backup services, cloud providers, bookkeeping offices, email services, transcriptionists, safeguards, IT consultants, software developers, etc.
Difficulties Faced by Developers While Creating HIPAA-compliant software
Almost any sort of healthcare software has to collect, process, and share certain medical data. In most cases, the data is confidential to varying degrees. On the one hand, every possible violation of data privacy hangs like a sword of Damocles over developers. On the other hand, HIPAA guidelines represent significant aid to software developers regarding the approaches to HIPAA-compliant systems.
Only high-class professionals are capable of coping with the development of such sort of software in the light of the following constraints and requirements:
Since the HIPAA act protects the privacy of patients, any data that can potentially authorize them must be securely stored inside the software solution. Any leakage of personal data must be prevented. Hence, there must be some code-level rules and algorithms against fraud and identity theft.
If software architecture implies different privilege levels, users of a certain level must not see any info related to upper levels. Such a functionality goes close to the HIPAA authorization form that gives permissions to use private health data for various purposes not directly linked to treatment, health insurance, and payment for healthcare services.
Despite the total security of data within applications, an opportunity to download/upload info with remote hardware data holders (memory sticks and the like) should be available.
All documents about the health status of every patient should be in a printable standard (PDF) and contain info about an attending doctor including the doctor’s signature (ideally handwritten). Regardless of what exactly HIPAA stands for the issue, all health insurance companies always require just handwritten signatures while the other organizations can accept doctors’ names printed in fonts somewhat similar to a handwriting style.
Integration with any third-party API is strictly prohibited. Any HIPAA-compliant software can be integrated with neither Google Calendar nor Facebook Pixel. The same relates to authorization via social media profiles: no way. Even a captcha from a third-party service is not acceptable. What’s more, just a trivial YouTube video in your application makes it non-compliant. No third-party fonts, no Google analytics.
Developers cannot use any addressing that contains personal data. The sort of addresses like “domain/path/client-name” is prohibited since patients’ names remain in the browser history.
Every action conducted via a HIPAA-compliant application is to be recorded in a corresponding log: when and who has logged in, through which device, from which location, at what time. Each user’s action leaves the track in a log. Any query for getting access to data (not to mention for altering information) cannot be executed without relevant permission.
How to Make Sure Your Project Meets HIPAA Compliance
To make your solution fully HIPAA-compliant, serious preparatory and improving measures should be taken. Let’s indicate them one by one.
First of all, you should conduct a meticulous audit of the customer’s IT infrastructure. In addition, policies, administrative workflows, and contractual relationships with available business partners should be assessed concerning HIPAA compliance.
In other words, an in-depth risk analysis should be made to arrange all necessary security measures. The following items have to appear under careful assessments to name a few:
All data management methods and technologies.
Security techs applied to health data protection.
Possible risk-inducing policies and technical shortcomings in both electronic health record apps and hospital management software.
All electronic databases and logs involved in health data storage.
All use cases of illegal access to health data, fraud attempts, and other HIPAA violation examples happened over the entire lifetime of the software systems under the audit.
Potential threats from possible health data breaches.
To minimize the risk of unauthorized access to health data the following cybersecurity improvements won’t go amiss:
Provide using only secure passwords having at least eight characters including special symbols and numbers.
Implement additional techs of users’ verification such as biometrics, face recognition, 2F authentication, and the like.
Create automatic termination of each logged session after a certain period of inactivity.
Use special tracking tools to detect suspicious behavior of users who can be temporarily banned.
Arrange multi-level access privileges when healthcare specs with different responsibilities have different rights to access health data.
Use E2E encryption technologies wherever possible. Provide converting sensitive health data into unreadable formats that require special keys to be decrypted. Such protocols as TLS/SSL, PGP, SSH, and even cryptographic SHA256 are worth considering.
Data recovery measures
Health data records must remain invulnerable despite whatever may happen with a healthcare facility. Natural disasters, emergency shutdowns, hacker attacks, and ransomware can threaten critical health files in both physical and digital environments. Software systems incapable of confronting those threats can hardly comply with the HIPAA security rules.
This is about using advanced backup methods and data recovery techs. The right emergency mechanisms of data protection can include the following:
Well-developed policies of health data backups.
Automated regular backups of critical health records.
Both on-premise and in-cloud secure data-storage facilities.
Well-scheduled inspection and maintenance of all hardware/software systems responsible for health data backups and recovery.
Contracting professional service providers capable of looking after regular backups of the most critical apps and health records.
Log tracking tools
Obtaining HIPAA certification for healthcare software is unlikely possible without properly developed log management. This is about efficient log tracking when a healthcare software solution allows responsible admins and security officers to check every logged session to see who access, update, delete, or change any file in health records.
AI-enabled algorithms capable of analyzing any attempt to do anything with sensitive health data can be implemented to send immediate notifications to the responsible security staff.
Efficient data-processing techniques
It is a norm to have some old data in records generally. However, a HIPAA-compliant solution has to follow more stringent data security rules. That’s why obsolete backups, data of former patients, unnecessarily duplicated info, and other sorts of informational contamination should be timely removed from healthcare apps.
Custom algorithms can be created to scan health databases continuously to eliminate those datasets that appear out of use for a certain period. The algorithms can be applied to audit backup storage and data archives.
Another aspect of efficient data management comes to checking the devices in which various pieces of health data can be left as occasional residuals (scanners, printers, USB drives, etc). This is about staff training with a special data management policy rather than about technical features that can conduct such checking automatically.
Special staff education
However secure your software can be, poorly educated staff can unintentionally compromise any healthcare workflow against the HIPAA security rules. Besides, newcomers should have an adaptation period to work with digital healthcare systems. Various HIPAA guidelines are remaining unknown for many medical specs. This issue relates to special staff education that can be provided by either a software vendor or a medical organization for which the staff works.
At the same time, any software vendor bears responsibility for all outcomes of a possible violation of HIPAA rules that may happen as a result of improper operation of particular healthcare software. That’s why special staff training is a must to provide the security level that corresponds to HIPAA regulations.
HIPAA Violation Examples
The following typical cases of HIPAA violation can help understand at which aspects of cybersecurity the developers should focus their attention while building HIPAA-compliant software.
Communication via unencrypted chats and messengers. This is about the light-minded approach to personal health data that can be mentioned when medical staff communicates via various digital channels. In contrast, encrypted communication apps prevent cybercriminals from getting access to sensitive health data even if they can intercept messages. The encrypted files remain unreadable without special private keys.
Hacking and ransomware attacks. Hackers are rarely interested in reading health records as such: they are trying to sell stolen info to either advertisers or other organizations that can benefit from the data somehow. They use phishing websites oftentimes to fraudulently obtain confidential personal data from users. Another method they use is ransomware when a particular dataset appears blocked unless a healthcare organization pays for the data unlocking. One of LA medical centers had to pay $17000 ransom in digital currency to bring back access to their health records.
Unauthorized access. This is the most common type of HIPAA violation. Data leaks happen when a healthcare organization has no well-established system of multi-level privileges for accessing confidential health data. When it comes to neither treatment nor payment, medical staff should get access to health data only via the written consent of attending doctors and data security managers.
Stolen devices. HIPAA security rules can be easily violated when corporate devices (laptops, phones, USB memory sticks, etc) are lost or stolen. Private health info of about 20K patients appeared at significant risk when a corporate MacBook was stolen from one of the employees of Rhode Island’s hospitals.
Social engineering. This method of getting to confidential health data does not imply technical means. Instead, cybercriminals use various social approaches to medical specs while persuading them to share health data via legal channels. Even sharing seemingly casual data with patient relatives can result in HIPAA violations.
Getting access from unsecured devices. Remote employees and patients’ relatives can unintentionally represent access to sensitive health data to hackers via their private unsecured devices. They can download malware by accident and provide access to health data during another communication session with a hospital. This is when cybercriminals try to attack the personal computers of staff and patients instead of hacking hospital systems.
The variety of entities can potentially be subject to the HIPAA law when they deal with healthcare organizations. Since the exchange of protected health data is conducted via digital communication channels mostly, software vendors that provide healthcare solutions must know the nuances of HIPAA regulation so as not to fail their business partners.
A certain set of data protection measures should be taken to make healthcare software HIPAA compliant. Cybersecurity enhancements, log tracking tools, and data recovery techniques are just some of the essential elements to be applied to a fully HIPAA-compliant software solution.
Not to face sorrowful outcomes of insufficient HIPAA compliance it is better to cooperate with those software developers whose competence in healthcare solutions is proved by a broad hands-on experience.
Contact us today if your project requires a deep understanding of HIPAA regulation along with professional software development.
If your project implies dealing with any sort of PHI (protected health information), no respected healthcare organization will do any business with you unless your solution is HIPAA-compliant. Not just doctors and hospitals, but a great variety of business associates such as health insurance companies, healthcare management programs, pharmacies, clearinghouses, and the like all expect your solution to comply with HIPAA security rules. Hence, your solution has to meet quite a specific set of cybersecurity requirements. At the same time, the issue is not rocket science when your software developers are aware of the advanced countermeasures against cyber threats that make healthcare software vulnerable.
Both insufficient technical means of data security and organizational failures can lead to HIPAA violation. Besides, certain staff’s ignorance about dealing with sensitive health data can result in violation of HIPAA security rules. The most common HIPAA violation examples include the following: Communication via unencrypted chats and messengers; Website phishing and ransomware attacks; Poor privilege systems allowing unauthorized access to PHI; Data leaks via stolen/lost hardware; Irresponsible sharing of PHI due to malicious social engineering; Representing access to PHI via unsecured devices.
Certain technical and organizational methods help make your software solution HIPAA compliant. They include, inter alia: meticulous audit of the customer’s IT infrastructure; assessment of policies, administrative workflows, and contractual relationships with available business partners; implementation of advanced cybersecurity approaches such as 2F authentication, automatic termination of sessions, E2E encryption, log tracking tools, multi-level access privileges, etc.; reliable data-recovery and backup technologies; efficient data-processing techniques; proper staff training.
You may share this article
Lassen Sie Profis Ihre Herausforderung meistern
Unsere zertifizierten Spezialisten finden die optimale Lösung für Ihr Unternehmen.