Healthcare technology, from sophisticated electronic health record (EHR) systems to mobile health app has transformed patient care delivery. These platforms promise improved care coordination, analytics and efficiency. Yet, as health data becomes more widely accessible in digital systems, challenges around privacy, informed consent and data security have emerged. Research and breach reports indicate the stakes are high: millions of patient records were affected by healthcare data breaches in 2025 alone.
In traditional medical settings, informed consent requires clinicians to explain the benefits, risks and alternatives of a treatment or procedure before the patient agrees to it. In digital health, informed consent similarly means patients should understand how their health data will be accessed, used, shared and protected. This extends to:
Who can view their medical records
What types of data will be accessed
How long the data will be stored
Whether third parties will receive any data
Consent is intended to be voluntary and clearly communicated, ensuring patients retain control over sensitive information.
Modern health technologies often centralize patient data to streamline clinician workflows.
However, when access controls or privacy safeguards are incomplete or poorly implemented, sensitive health information can be visible to individuals who are not authorized or have not received explicit patient consent.
This can include detailed clinical notes, mental health records or messaging between a patient and clinician. Research highlights that privacy risks increase with more stakeholders, data sources and technologies involved in the digital ecosystem.
In one reported professional demonstration of a digital health platform, a teenager’s detailed clinical notes including mental health information were visible without clear evidence of consent for access, raising questions about whether patients were informed or agreed to such exposure. This example illustrates how technical access ease can outpace ethical and legal consent processes when privacy controls do not enforce consent barriers before data is opened.
The potential consequences of lax consent controls are compounded by ongoing security vulnerabilities. In 2025, healthcare data breaches continued to affect millions of patients:
As of late 2025, nearly 57 million individuals’ protected health information was reported compromised through data breaches affecting 500 or more individuals.
High-profile breaches included attacks on large institutions and vendors, such as the Yale New Haven Health System breach, which exposed sensitive data of over 5.5 million individuals.
Other breaches involved insurance and healthcare service entities, affecting millions more through unauthorized access to personal identifiers and clinical data.
These incidents illustrate that data privacy risks are not hypothetical and that unauthorized access whether from cyberattacks or internal oversights can affect large populations.
Privacy protections such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States are designed to safeguard protected health information (PHI) and set standards for consent, security and breach notifications. Under HIPAA:
Covered entities must implement safeguards to prevent unauthorized access to PHI.
Breaches affecting 500 or more individuals must be reported to regulators and affected individuals.
Patients have rights to access and request corrections to their medical records.
Despite such frameworks, regulatory protections can lag behind rapidly evolving digital technologies, as legislative standards often respond to past developments rather than proactively anticipate new risks. Moreover, HIPAA does not cover all forms of health-related data, such as activity tracker data or some mobile app–collected information, leaving gaps in patient privacy protections.
Globally, laws like the EU’s General Data Protection Regulation (GDPR) provide additional patient rights such as data access and deletion, but inconsistent global frameworks can result in uneven protections.
Privacy concerns in healthcare technology extend beyond large breaches:
Unauthorized internal access: Systems lacking robust access controls may allow personnel to view records without clear consent or legitimate clinical reason.
Secondary uses of data: Patient data may be used for research, analytics or third-party services without patients fully understanding the implications or having given explicit, informed consent.
Mobile health app risks: Information collected through smartphone apps—such as health tracking, symptom logs or therapy messaging—may be shared with third parties or remain insufficiently protected.
These scenarios highlight that privacy challenges are not only related to breaches but also to how data is managed, shared and governed within digital ecosystems.
To address consent and privacy challenges in digital health, best practices emphasize:
Privacy by design: Integrating consent requirements and privacy controls from the earliest stages of system development rather than as add-on features.
Clear consent mechanisms: Ensuring patients understand and actively agree to specific uses of their data before access is granted or shared.
Granular controls: Allowing patients to tailor who can view what parts of their information and when.
Regular audit trails: Logging and transparently reporting access to patient records so patients and institutions can monitor who accessed what and why.
These approaches support patient autonomy and align technical capability with ethical standards for handling sensitive health data.
Healthcare technologies offer significant advantages for clinical care and research, but they also present complex privacy and consent challenges. Even well-designed electronic systems can risk exposing data if consent mechanisms and privacy safeguards are not robust. The prevalence of large healthcare data breaches in 2025 underscores the broader context in which these risks operate, emphasizing that security and consent are essential components of trusted digital health innovation.
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