As of November 2022, the Office for Civil Rights (OCR) has settled 126 cases of HIPAA violations for over $133 million. OCR has intervened in 52,000 cases and guided HIPAA-covered entities before investigations or penalties were needed.
Over the last couple of decades, healthcare organizations have faced exponentially increasing threats tied to cybercrimes targeting personal health information. Are you wondering how to maintain HIPAA compliance in software development for web and mobile applications?
In this article, you will learn about what HIPAA compliance means for healthcare software development partners and what steps to take to build custom HIPAA-compliant software solutions.
What does HIPAA compliance mean for healthcare software development partners?
On February 17th, 2023 the United States Health and Human Services Office for Civil Rights released two executive reports to congress focused on healthcare data breaches, HIPAA compliance, and the evolving cybersecurity threat environment that healthcare providers are facing.
During 2021, the OCR received more than 34,000 complaints of alleged HIPAA and HITECH violations—a 25% increase from just the previous year. As of 2023, the healthcare industry remains the most fiercely targeted by cybercriminals with large-scale hacking operations.
“The healthcare industry is one of the most diverse industries in our economy, and OCR is responsible for enforcing the HIPAA Rules to support greater privacy and of individuals’ protected health information,” said OCR Director Melanie Fonte. “We will continue to provide guidance and technical assistance on compliance with the HIPAA Rules, as well as a vigorous enforcement program to address potential HIPAA violations.”
HIPAA compliance is essential for healthcare organizations to manage risks, reduce costs and realize their full potential as business units. These recent reports to congress outline a pervasive threat environment that underscores the need for providers to complete strategic investments to ensure all software solutions used across their developmental footprints are HIPPA compliant.
2022 HIPAA Data Privacy Reports Delivered to the U.S. Congress
The 2021 Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance outlines the number of HIPAA complaints received, the methods the government used to resolve those complaints, the number of complaints initiated internally through the OCR as well as the outcome of each case that was reviewed.
The Annual Report to Congress on Breaches of Unsecured Protected Health Information outlines the threat environment healthcare providers are facing and outlines the number and scope of breaches of unsecured protected health information (PHI).
This report also identifies best practices for improving compliance with key HIPAA Security Rule provisions such as:
- Risk analysis and risk management processes
- Information system activity reviews
- Audit controls and access controls.
Key HIPAA Provisions for Healthcare Software Development
Under HIPAA, all physicians, mental health providers, pharmacies, and healthcare organizations that have access to personal health information are considered “covered entities” and are subject to the reporting, disclosure, and documentation standards of the law.
‘If a healthcare development company interacts with a solution that gathers and processes personal identifiers of patients, HIPAA standard applies to the software provider.’
Under HIPAA guidelines, every organization that is considered a covered entity or business associate must be compliant with the law. Business associates are defined under the law as a person or company that offers services to the covered entity resulting in the disclosure of personal health information. All software firms in the healthcare industry that keep, share, or simply have access to identifiable health information of patients must be HIPAA compliant.
“Healthcare software used to collect, amass, store, transmit, and/or operate PHI must comply with HIPAA and adhere to its laws and regulations. However, if an application does not handle protected health information, it is excused from HIPAA compliance.”
There will be consequences if the software violates any HIPAA compliance restrictions. Thus, it’s critical to understand how to make a healthcare software program HIPAA-compliant.
Build HIPAA Compliant Healthcare Software
FAQ
- In 2021, how many HIPAA and HITECH complaints were filed?
During 2021, the OCR received more than 34,000 complaints of alleged HIPAA and HITECH violations—a 25% increase from just the previous year. As of 2023, the healthcare industry remains the most fiercely targeted by cybercriminals with large-scale hacking operations. - What does HIPAA compliance mean for healthcare software development partners?
On February 17th, 2023 the United States Health and Human Services Office for Civil Rights released two executive reports to congress focused on healthcare data breaches, HIPAA compliance, and the evolving cybersecurity threat environment that healthcare providers are facing.“The [healthcare] industry is one of the most diverse industries in our economy, and OCR is responsible for enforcing the HIPAA Rules to support greater privacy and of individuals’ protected health information,” said OCR Director Melanie Fonte. “We will continue to provide guidance and technical assistance on compliance with the HIPAA Rules, as well as a vigorous enforcement program to address potential HIPAA violations.” HIPAA compliance is essential for healthcare organizations to manage risks, reduce costs and realize their full potential as business units. These recent reports to congress outline a pervasive threat environment that underscores the need for providers to complete strategic investments to ensure all software solutions used across their developmental footprints are HIPPA compliant. - What are some of the main provisions of HIPAA for healthcare software providers?
Under HIPAA, all physicians, mental health providers, pharmacies, and healthcare organizations that have access to personal health information are considered “covered entities” and are subject to the reporting, disclosure, and documentation standards of the law. ‘If a healthcare development company interacts with a solution that gathers and processes personal identifiers of patients, HIPAA standard applies to the software provider.’ Under HIPAA guidelines, every organization that is considered a covered entity or business associate must be compliant with the law. Business associates are defined under the law as a person or company that offers services to the covered entity resulting in the disclosure of personal health information. “All software firms in the healthcare industry that keep, share, or simply have access to identifiable health information of patients must be HIPAA compliant.” HIPAA (Health Insurance Portability and Accountability Act) is the most critical and substantial privacy regulation governing the US healthcare industry. The Office for Civil Rights (OCR) is the main federal agency responsible for protecting patient privacy rights.
Privacy Rule
This rule was designed to allow personal health data to move through the community health network without allowing fraud to negatively impact patients. This guideline also grants patients the right to examine, receive copies, and require changes to their health records.
Security Rule
The security rule sets the standard by which any electronic health records must be generated, received, used, and maintained by covered entities. Under this rule, entities must provide”adequate administrative, physical, and technological protection to maintain the confidentiality, integrity, and security” of ePHI.
Compliance Rule
The enforcement rule stipulates how the Department of Health and Human Services (HHS) will enforce HIPAA and what penalties will be rendered for non-compliance.
Notification Regulations
The section requires HIPAA-covered entities to immediately disclose the unauthorized breach of any electronic health data.
General Rule
It establishes the rules concerning interoperability in healthcare solutions and alters numerous HIPAA Privacy, Security, and Enforcement rules, making it more difficult to dodge breach reporting, expanding non-compliance responsibility to business partners, and imposing additional privacy limits for the use of PHI. “Healthcare software used to collect, amass, store, transmit, and/or operate PHI must comply with HIPAA and adhere to its laws and regulations. However, if an application does not handle protected health information, it is excused from HIPAA compliance.”There will be consequences if the software violates any HIPAA compliance restrictions. Thus, it’s critical to understand how to make a healthcare software program HIPAA-compliant.
