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    Home » Regulatory Oversight and Enforcement Mechanisms for Cloud-Based HIS in India
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    Regulatory Oversight and Enforcement Mechanisms for Cloud-Based HIS in India

    November 19, 2024By QH Editorial Team
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    • November 19, 2024
    From getting medical advice from a doctor on your device to getting medicines delivered to your doorstep just via the clicks on your phone. Healthcare Cloud-based health information systems (HIS) have been increasingly gaining popularity in recent years. HIS has completely changed the way healthcare data is accessed, handled and stored. These systems provide benefits in terms of affordability, accessibility, and scalability. Despite offering several advantages, there are various security issues with exchanging and storing private health information on the cloud. The potential disclosure of health information to unauthorised individuals poses a serious problem.

    What opt Cloud-based health information systems (HIS)?

    Cloud-based HIS enables medical staff members to access patient information and data from any location with internet connectivity thus introducing concepts like remote consultations and telemedicine, enhancing accessibility across the globe. Unlike traditional IT systems, cloud-based HIS are flexible to fluctuating healthcare demands and evolving organisational needs.  Which in turn Improves collaboration and interoperability- by facilitating seamless data exchange across various healthcare systems and providers. Thus leading to collaborative care coordination.

    Concepts like personal electronic health records (pEHR) and e-health have been evolving to improve patient outcomes and empower the growth of cloud services and providers. There have been certain advancements in IT, medical and Medicaid sciences due to which current HIS have become more complex and expected to perform certain functions. One of the major functions is Clinical information management. This pertains to data about patients and includes electronic health records (EHR), data retrieved from internal submodules, or integration with external systems. These resources may be from radiology departments, inpatient or outpatient facilities, emergency rooms, or pharmacies. This category also includes order communication systems, knowledge bases, and clinical decision assistance.

    Another function performed is Operational Management. This category includes all non-clinical related tasks like payroll and billing in the financial department. In addition, supply chain management, engineering, maintenance, and procurement also fall into this category. Concepts like better market trends, competition behaviour and marketing insights aid in improving organisational control and strategic planning. Additionally, Electronic networking performs an important function and includes any interface that enables the transfer of health information across a network.

    Challenges:

    Numerous issues arise from the disturbed architecture of the cloud, including those related to regulation and standards, privacy, security, data ownership, and interoperability. A patient’s medical history is encrypted and stored in a virtual vault within the cloud, but who holds the key to unlock this?  This question brings us to a very important point of addressing and navigating the challenges faced due to Cloud-based HIS in India and the world.

    A major consideration is the processing, storage and consent regarding the digital data of individuals.  Hacking and data destruction are the major data breaches posing risks to the security of patient data. Cloud-based healthcare information systems incorporate issues like insider threats, password weakness, unauthorised access, and device theft which makes it vulnerable to malware. This can in turn compromise patient data integrity and network security. The Data Protection Act of 2023 may impose fines for such violations. Healthcare organizations must ensure that their cloud-based HIS adheres to the Digital Personal Data Protection Act, 2023 to safeguard data protection, purpose limitation, and data minimization. Furthermore, for enterprises managing patient data belonging to residents of the European Union (EU), compliance with international regulations like the General Data Protection Regulation (GDPR) is essential.

    The probability of medical negligence increases while switching from paper records to electronic medical records. Although it ensures that there is better accessibility of evidence for legal defence, system failures could jeopardise patient care and legal compliance. Leading to an increase in cases of medical malpractice.

    How is Cloud-Based Health Information Systems in India regulated?

    • Information Technology Act, 2000 (IT Act)- establishes the legal foundation for digital signatures, cybersecurity, and electronic recordkeeping. It contains clauses about the electronic preservation, exchange, and security of health data. Cybercrimes, such as unlawful access to health data kept in cloud-based HIS, are likewise covered by the IT Act.
    • Digital Personal Data Protection Act, 2023: This Act attempts to control the handling and safeguarding of personal data, particularly health-related data. It highlights ideas like accountability, purpose limitation, and data minimisation. Stricter guidelines for getting permission, localizing data, and notifying of data breaches are introduced by the act and are relevant to the functioning of cloud-based HIS.
    • Clinical Establishments (Registration and Regulation) Act, 2010- This Act incorporates the registration and regulation of clinical establishments, including hospitals, clinics as well as diagnostic centres. Though these do not specifically include cloud-based HIS, it might have clauses on patient records, confidentiality, and adhering to ethical standards in healthcare delivery.

    The Road Ahead:

    The digitisation of healthcare in India raises ethical questions in addition to legal ones. The main ethical concerns centre on informed consent, which is a crucial issue that should be given special attention to underprivileged sections of the society i.e. those with poor literacy rates and communities that have a history of medical exploitation. A thorough framework for data protection and informed consent framework is needed for digital healthcare to reach the masses. Thus, it is important to implement a rights-based framework for health to prioritise informed consent, control user data, and promote the right to access healthcare.

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    • QH Editorial Team
      QH Editorial Team

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    Cloud Technology DPDPA EU Regulations Healthcare HealthTech Information Technology Act
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