In the wake of the Supreme Court recognizing citizens' privacy as a fundamental right, it has set off a series of events within the digital sphere. Before the introduction of the 2023 DPDP (Digital Personal Data Protection ) bill by the Indian government, several bills were under consideration. With the enactment of the DPDP Bill significant implications have emerged for safeguarding sensitive healthcare data. This blog post aims to explore the fundamental aspects of the DPDP Bill and how it affects the healthcare sector. It's important to note that the DPDP Bill has a reach that extends beyond healthcare to encompass other sectors where digital data is generated in India.
Key Terminology in the Healthcare Context
1. Data Principal: This term refers to the patient or, in the case of minors, their parents or legal guardians.
2. Data Fiduciary: In healthcare, this term primarily refers to healthcare providers like hospitals, labs, and clinics.
3. Data Processor: This term is used to describe your HIMS (Health Information Management System) vendor, call centers in case of healthcare is using for marketing.
Compliance with ABDM for Healthcare
By adopting an ABDM-compliant HIMS, healthcare entities automatically align themselves with the DPDP Bill. If you are currently using a non-ABDM HIMS, it is advisable to transition to an ABDM triple milestone-compliant HIMS, such as Nice HMS.
Responsibilities of Data Fiduciaries
In the realm of DPDP, the lion's share of responsibilities falls on the Data Fiduciary, particularly within the healthcare sector. Therefore, it is of utmost importance to meticulously select a vendor committed to protecting data and refraining from selling it.
Storing Health Data within India
A fundamental requirement of the DPDP Bill is that health data must be stored within India. It is imperative to confirm this compliance before engaging with an HIMS vendor.
The Significance of Data Principal's Consent
The DPDP Bill underscores the significance of the Data Principal, which is the patient's consent. Obtaining consent is a vital aspect of the DPDP Bill, ensuring that data collected is used only for the purposes consented to by the patient. Consent should be clear, specific, and informed, as vague or generic consent is not considered valid and could be misleading.
Data Usage and Consent
If data is to be used for any purpose other than what was initially consented to, it is the responsibility of the Data Fiduciary to obtain consent from the Data Principal before the Data Processor can proceed.
Anonymized and Pseudo-Anonymized Data
Another crucial aspect is the handling of anonymized or pseudo-anonymized data. Anonymized data refers to data that has been modified in a way that makes it impossible to re-identify the Data Principal; this is rare in the real world. Pseudo-anonymized data involves masking the Data Principal's identity, and while there may be some flexibility for genuine research, medical ethics still require obtaining informed consent from the Data Principal. It is advisable to seek consent from the Data Principal before processing data for research, even though this may not always be feasible.
Data Processing and Legal Obligations
For commercial purposes, when using anonymized data, it is recommended to obtain consent from the Data Principal via the Data Fiduciary. Please note that the Data Processor can only proceed with data processing after obtaining consent from the Data Fiduciary, as the Data Fiduciary serves as the legal guardian of patient data, bearing the primary legal obligations. Any act that in anyway hurts the patient privacy could call for legal action by data protection board.
Handling Data Breaches and Ensuring Data Protection
In case of a data breach, it is the primary responsibility of the Data Fiduciary to inform the Data Principal. Therefore, it is crucial to choose your HIMS vendor responsibly and ensure they have robust data breach notification mechanisms in place. It's also vital to emphasize that refraining from selling patient data is an essential ethical practice in healthcare, reinforcing trust and compliance with data privacy regulations.
The DPDP Bill has ushered in a new era of data protection, particularly in the realm of healthcare. It emphasizes the importance of informed consent, the responsibility of data fiduciaries, and the secure management of healthcare data. The need to store health data within India and the significance of compliance with ABDM standards cannot be overstated. As healthcare providers and organizations navigate these new regulations, it's essential to recognize that data privacy is paramount. By adhering to the DPDP Bill's principles, diligently protecting data, and ensuring that patient data is not being sold, healthcare data can be effectively safeguarded, ensuring both patient trust and legal compliance in this ever-evolving digital landscape.