Can Pharmaceutical AI Usage Violate HIPAA?

Summary
Pharmacies must be careful when handling sensitive data using AI tools to avoid HIPAA violations. Insufficient risk assessments, unsecured data storage, lack of access controls, and more can risk noncompliance when utilizing AI. Pharmacies should remember to enforce strict compliance rules if allowing employees to use AI.- Author Company: ReHack
- Author Name: Zac Amos
- Author Email: zac@rehack.com
- Author Website: https://rehack.com/
In recent years, artificial intelligence (AI) has infiltrated every industry, streamlining processes, optimizing insights and improving evidence-based decision-making. Pharmacies, in particular, have utilized AI tools to provide more personalized care and medication management, identify possible drug interactions, educate patients and enhance telemedicine.
However, utilizing AI in healthcare and pharmaceuticals is not without caveats. Without robust guidelines and compliance, pharmacies walk a fine line regarding patient privacy violations.
How Do Pharmacies Encroach Patient Privacy With AI Solutions?
Pharmacies must be careful when handling sensitive data using AI tools. These six considerations make Health Insurance Portability and Accountability Act (HIPAA) noncompliance a likely risk to patient confidentiality and protection.
1. Insufficient Risk Assessments
Conducting comprehensive risk assessments is a critical first step in implementing AI technologies within pharmacies. Without proper evaluation of potential security risks and privacy concerns, pharmacies could inadvertently compromise patient details.
Failure to address oversights increases HIPAA noncompliance through unauthorized access and data breaches. As a result, pharmacies may face significant legal and financial implications. Regularly updating mitigation strategies and processes as part of their AI risk assessments and ensuring detailed documentation is essential.
2. Unsecured Data Storage
According to one study, 58.9% of respondents expressed concern about AI system vulnerabilities to hacking and cybersecurity threats. Poor encryption and prohibited system access often drive these issues, raising the potential for HIPAA transgressions.
Robust data storage security prevents the misuse of patient data. For example, pharmacies should employ several encryption strategies, such as the Advanced Encryption Standard for servers and databases, Transport Layer Security for data transfers between systems, tokenization to prevent patient exposure and end-to-end encryption to ensure confidentiality throughout the entire data life cycle.
3. Unauthorized Disclosure of Patient Data
Sharing patient data with AI vendors and partners could violate HIPAA without proper security. This oversight may result in unauthorized third parties obtaining sensitive information and mishandling it for personal benefit.
The forbidden disclosure of patient medical information is one of the more common HIPAA compliance issues that the Office of Civil Rights regularly investigates. Pharmacies disregarding safeguards and agreements to prevent such infractions could be penalized between $13,785 and $68,928 per violation if the problem is corrected immediately. Without correction within 30 days, they could be fined $68,928-$2,067,813 per violation.
4. Lack of Access Controls
Patient privacy is more secure with sufficient access controls in place, such as role-based clearances and multifactor authentication. Without them, unauthorized users could obtain sensitive information stored in AI systems and expose peoples' health records.
In 2024, 32% of cyberattacks comprised data theft and leaks, demonstrating how attackers now prefer stealing and selling data over encrypting it for extortion. Zero-trust architecture can better prevent these attacks through robust verification and least privilege access.
Least privilege access limits users' access to systems based on the minimum permissions they need for their jobs. This significantly reduces the probability of data getting into the wrong hands and committing HIPAA violations.
5. Overreliance on AI Algorithms
Pharmacies that overdepend on AI algorithms could imperil patient privacy and security by generating inaccurate insights and determinations. For instance, hospital-transmitted information may be of poor quality or have missing or incorrect data points, leading to errors in medical data processing and a lack of accountability when things go wrong.
Erroneous outputs may then result in inappropriate treatments or unauthorized patient information disclosure — a serious HIPAA violation that impedes patient trust.
6. Insufficient Data Anonymization
Failure to effectively terminate or encrypt identifiable patient information from AI algorithms goes against HIPAA principles in protecting identities. AI tools train on the data they're fed, which means specific details like names, contact information and medical records may become compromised.
Anonymization removes any link to the patient, preventing AI-derived insights from being traced to the individual.
Ensuring HIPAA Compliance With AI Tools
Pharmacies must enforce stringent HIPAA compliance rules when utilizing AI tools to protect patients, such as the following:
- Train employees on proper AI use based on risk assessment outcomes.
- Encrypt patient data while at rest and in transit to avoid unauthorized access.
- Secure all channels before sharing patient information across systems.
- Test and validate AI algorithms for maximum accuracy and security.
- Avoid storing patient data longer than necessary and create proper information disposal measures.
- Impose robust access controls and authentication to limit system entry to authorized users.
- Ensure transparency throughout the patient data life cycle.
- Reassess the potential for breaches and noncompliance risks regularly.
Protecting Patient Details in the AI Era
AI solutions will continue to develop and streamline pharmacy processes in the future. Therefore, the healthcare sector must implement policies and compliance measures to uphold HIPAA. Patient protection must be every pharmacy's top priority with every new AI integration.