Digital Health Records and Informed Consent: Legal Challenges in the Adoption of Electronic Medical Systems

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@article{1709724,
      author = {Augustine Onyeka Okoli, Irene Sagay, Sandra Oparah, Opeoluwa Oluwanifemi Ajayi, Collins Nwannebuike Nwokedi},
      title = {Digital Health Records and Informed Consent: Legal Challenges in the Adoption of Electronic Medical Systems},
      journal = {Iconic Research And Engineering Journals},
      year = {2019},
      volume = {3},
      number = {4},
      pages = {278-294},
      issn = {2456-8880},
      url = {https://www.irejournals.com/formatedpaper/1709724.pdf},
      abstract = {The rapid adoption of Electronic Medical Systems (EMS) and Digital Health Records (DHR) has significantly transformed healthcare delivery, enhancing data accessibility, efficiency, and continuity of care. However, this digital shift has also introduced complex legal challenges, particularly regarding informed consent. Traditionally grounded in principles of patient autonomy and the right to self-determination, informed consent requires that patients fully understand the nature, purpose, and implications of their medical care. In the digital context, this obligation becomes more intricate due to the vast and often opaque processes surrounding data collection, storage, sharing, and automated decision-making. One of the primary legal concerns is the complexity and comprehensibility of digital consent mechanisms. Many consent forms presented within EMS platforms are overly technical, reducing patients? ability to make informed choices about data usage and sharing. Additionally, there is growing legal scrutiny of the validity of consent obtained through digital interfaces, especially where automated systems, artificial intelligence (AI), or algorithmic nudging influence decision-making processes. These technologies raise questions about the sufficiency of ?informed? consent and whether patients can meaningfully control their health information. Data privacy and cybersecurity risks further complicate informed consent. Cross-border data transfers, cloud storage, and third-party integrations heighten exposure to breaches and unauthorized access, challenging compliance with stringent data protection laws such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA). Jurisdictional variations in legal recognition of electronic consent and differing cybersecurity standards create additional compliance complexities for healthcare providers. This highlights the urgent need for legal reforms and patient-centered technological designs to ensure that informed consent remains effective and meaningful in digital healthcare environments. It underscores the necessity of harmonized legal frameworks, robust cybersecurity measures, and accessible, transparent consent processes to uphold patient rights in the era of digital health records and electronic medical systems.},
      keywords = {Digital Health Records, Informed Consent, Legal Challenges, Adoption, Electronic Medical Systems},
      month = {October},
  }