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Key Highlights
In 2022, more than 590 healthcare organizations experienced a data breach at an average cost of $4.35 million per event.
The Health Insurance Portability and Accountability Act (HIPAA) was signed into law in 1996 and has become the most significant legislation governing patient privacy and the use, transmission, and storage of personal health information (PHI).
Healthcare organizations are being targeted daily due to the value of personal health record (PHR) data on the dark web and other illicit marketplaces. In response, insurance providers are increasingly mandating third-party risk management, encompassing implementing cybersecurity and data governance best practices.
The Three Pillars of HIPAA Compliance
- Confidentiality: Personal health information must only be shared in approved methods with HIPPA-compliant entities
- Integrity: Data must remain preserved and unaltered, whether intentionally or unintentionally
- Access: All stakeholders in the community healthcare matrix have proper and timely access to personal health records
Healthcare organizations and the third-party vendors they work with have a vested interest in delivering HIPAA-compliant software applications to reduce the opportunity for cybercriminals to access organizational data.
In 2022, 12 data breaches were reported targeting healthcare organizations resulting in the loss of 1 million records, and a further 13 data breaches exposed between 500,000 and 1 million records. Most of the data losses were caused by supply chain cyber attacks against health insurance plans, with additional attacks coming via business associates, healthcare clearinghouses, and providers. Healthcare organizations and the third-party vendors they work with have a vested interest in delivering HIPAA-compliant software applications to reduce the opportunity for cybercriminals to access organizational data.
Over the last few decades, healthcare organizations have faced exponentially increasing threats tied to cybercrimes targeting personal health information. How do you maintain HIPAA compliance in software development for web and mobile applications?
In this article, you will learn 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 face.
During 2021, the OCR received over 34,000 complaints of alleged HIPAA and HITECH violations—a 25% increase from 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. It 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 with access to personal health information are considered “covered entities” and are subject to the law’s reporting, disclosure, and documentation standards.
‘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 considered a covered entity or business associate must comply 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 U.S. healthcare industry. The Office for Civil Rights (OCR) is the primary federal agency 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 impact patients negatively. 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 covered entities must generate, receive, use, and maintain any electronic health records. 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. It alters numerous HIPAA Privacy, Security, and Enforcement rules, making it more challenging to dodge breach reporting, expanding non-compliance responsibility to business partners, and imposing additional privacy limits for using the PHI.
“Healthcare software used to collect, amass, store, transmit, and 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.
The Key Components of HIPAA-Compliant Software
The absolute best compliance software is the solution that is custom designed to meet the needs of your healthcare organization. There is no one size fits all solution, and every organization needs to select a software solution that will provide the utility they need to meet their organization’s unique compliance obligation.
Security Risk Assessment Tools
HIPAA compliance requires regular security risk assessments to be conducted regularly according to federal regulations. An assessment is a baseline snapshot of an organization’s security and privacy practices as they are in place regarding meeting current HIPAA compliance obligations.
Security and Data Governance Playbooks
After completing your needs analysis, your organization will be able to use compliance software to develop a new plan to mitigate the risks that were uncovered. Following your plan is essential to reducing your risk, and your organization may suffer fines or criminal penalties for failure to comply.
Policies and Procedures
Your new software will allow your management team to create governance structures to ensure your employees, vendors, and partners implement your policies and procedures to limit compliance risk. Your software will help to streamline these practices so that many of these requirements are fulfilled using automated processes.
Documentation Tools
One of the most time-consuming aspects of HIPAA compliance is documenting measures taken to fulfill the necessities of the law. Documentation tools make it easier to access, update and share critical documents with regulators and other stakeholders across the healthcare matrix.
Business Associate Management
Before sharing data with third-party vendors, your organization must execute contracts known as business associate agreements to reduce liability if a supply chain partner experiences an attack leading to a data loss event.
Healthcare Information Security: Leveraging Blockchain Technologies to Support HIPAA Compliance
Blockchain technologies are emerging as strong development choices for building HIPAA-compliant solutions due to the transparency and interoperability they support.
In the coming years, more healthcare organizations will adopt healthcare information securities protocols built leveraging key features from emerging blockchain technology:
- Decentralization: Blockchain solutions remove the need to rely on semi-trusted third-party entities that pose a significant risk due to supply chain cyber-attacks.
- Pseudonymity: Blockchain architecture, by design, protects identities and creates unique opportunities for expanded access management.
- Autonomy: Across the blockchain networks, users maintain access to their PHI and decide who and when to share information.
- Auditability: All records are securely maintained for posterity across blockchains, making it easier to verify compliance.
- Incentivization: The collective and open-source nature of blockchain solutions makes it easier for diverse stakeholders to develop HIPAA-compliant solutions in tandem with each other.
Blockchain is an emerging technology like artificial intelligence, machine learning, and business process automation that is being applied to deliver innovative healthcare product development solutions across the industry.
Blockchain networks offer a unique means of seamlessly preserving and exchanging patient data and moving it between hospitals, diagnostic laboratories, pharmacy firms, and physicians without compromising confidentiality or integrity and ensuring proper access along every touchpoint in the healthcare matrix.
Software development experts believe that blockchain solutions will be used shortly to identify risk management focus areas more quickly before they lead to adverse outcomes for medical service providers. Blockchain technology offers more robust performance, security, and transparency of data exchange, making it easier for healthcare organizations to share information and maintain HIPAA compliance safely.
Conclusion
Ready to build HIPAA compliant software? Get in touch today.
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Vinod
Founder & Chief Strategist
Vinod is a deeply devoted digital health enthusiast who believes technology is a great enabler that provides the key to unlocking a better world. He is driven by a singular goal: to help healthcare organizations leverage technology to deliver better digital services for patients, providers, payers, and other community health stakeholders. His expansive computer science domain expertise, humanity, and commitment to community are major assets for healthcare, medical, pharmaceutical, and life science enterprises.
