As with other industries, the healthcare sector faces numerous challenges in ensuring the protection of patient data and complying with constantly progressing regulations. Healthcare technologies present a complex regulatory maze that requires organizations to navigate carefully to safeguard sensitive information. This article explores the significance of data protection, delves into the terms PHI and PII, and provides an overview of existing regulations on data security in healthcare.
The Significance of Data Protection in Healthcare
Data protection plays a pivotal role in maintaining patient trust, promoting efficient healthcare operations, and mitigating risks associated with data breaches. Patient data, i.e., PHI and PII, is highly sensitive and requires robust safeguards to prevent unauthorized access, use, or disclosure. Let’s have a closer look at what PHI and PII are.
Protected Health Information (PHI) is any health information that you can use to identify a person. It includes demographic data (i.e., name, address, birth date, social security number) and any medical data that can help identify a person. Businesses shall be extremely cautious while adding, managing, or transferring sensitive data in order to safeguard the patient’s right to privacy.
Personally Identifiable Information (PII) is a bit broader term that encompasses any information that can be used to identify an individual. Within healthcare, PII often overlaps with PHI as it also includes personal details such as names, addresses, phone numbers, email, social security numbers, and financial information.
Regulations in Data Security Applicable to Healthcare
Below is provided a brief overview of the major data protection regulations adopted in the US and EU. Following these regulations is vital for ensuring that the patient’s sensitive data is duly treated. This section would come in handy for the software development companies that provide outsourcing services. When working with third-party vendors or service providers, data holders must ensure they adhere to the necessary data protection standards and have appropriate security measures in place. Contracts or agreements that clearly define data handling responsibilities and liabilities are mandatory prior to starting the cooperation.
Health Insurance Portability and Accountability Act (HIPAA)
HIPAA is a paramount legislation in the United States that sets the standard for protecting PHI. It is by far the golden standard for protecting individuals’ medical records and other personal health information stored by healthcare service providers. Through services like duplocloud compliance, organizations must comply with HIPAA regulations to ensure the privacy and security of patient data.
HIPAA covers any types and forms of interaction that involves patients’ PHI and PII. Be that personal texts or emails with the physicians or discussions with other specialists, healthcare providers and their staff are obliged to make sure that sensitive information remains private.
The Health Information Technology for Economic and Clinical Health (HITECH) Act
The HITECH Act, as part of the American Recovery and Reinvestment Act (2009), extends and strengthens HIPAA’s privacy and security provisions. It points out the use of electronic health records (EHRs) and promotes the adoption of technology to enhance healthcare quality and efficiency. The Act includes breach notification requirements and provisions for enforcing penalties in case of non-compliance. In the Final Rule, the Act allows patients to restrict access to their PHI if the services were paid in full and out of pocket to the providers.
In addition to federal and international regulations, many states in the USA have enacted their own data protection laws. For example, the California Consumer Privacy Act (CCPA), the New York SHIELD Act, or the Massachusetts Data Security Law, impose specific data security requirements on organizations operating within these states. Healthcare organizations must ensure compliance with both federal and state regulations to maintain data security and protect patient information.
Medical Device Regulation (MDR)
In the European Union, the Medical Device Regulation (MDR) aims to ensure the effectiveness and safety of medical devices. While primarily focused on device safety, the MDR also addresses the protection of patient data. It imposes strict obligations on medical device manufacturers to implement appropriate security measures to protect against unauthorized access or alteration of data stored or transmitted by the devices.
General Data Protection Regulation (GDPR)
GDPR is a European legislation and similarly to CCPA is not limited to healthcare solely. The GDPR strengthens data protection rights and imposes strict obligations on organizations to handle personal data securely. Healthcare organizations operating in the EU or processing data of EU residents (e.g., companies outside the EU that work with the personal information of EU citizens) must adhere to the GDPR’s principles, including obtaining consent, implementing appropriate security measures, and reporting data breaches.
The EU’s Cybersecurity Act is a regulation that aims to strengthen the level of cybersecurity and advance the resilience of networks and information systems against cybersecurity threats. It promotes a coordinated approach to cybersecurity, including healthcare systems, and encourages the development of cybersecurity certification of ICT products and services. Compliance with the act can also help healthcare organizations strengthen their cybersecurity measures and protect patient data from potential cyber threats. The certifications under this Act can be voluntary or mandatory and are defined based on individual operations. Yet, the European Commission is currently considering making data security certifications compulsory for organizations operating in the EU zone or partners from outside.