Beyond Consent: Ensuring Meaningful Protection of Genetic Data Under India’s Digital Personal Data Protection Act, 2023

Beyond Consent: Ensuring Meaningful Protection of Genetic Data Under India’s Digital Personal Data Protection Act, 2023
Review Article
RK Singh, Vini Singh
Journal of Indian Academy of Forensic Medicine, 10 April 2025
Open Access
Abstract
   India’s Digital Personal Data Protection Act (DPDPA) adopts a notice-and-consent-based framework for data protection; it treats all personal data, including genetic data, as a singular category without accounting for its unique characteristics. Unlike ordinary personal data, genetic data is inherently relational; it reveals information not just about an individual but also their biological relatives. Moreover, the risks associated with the processing of genetic data extend beyond identifiability, such as the potential for its misuse in law enforcement or to discriminate in matters of employment or insurance. Despite these concerns, the DPDPA fails to offer a nuanced regulatory approach, lacks a clear definition of genetic data, and does not impose heightened safeguards for its processing.
This article identifies the limitations of the DPDPA’s notice-and-consent-based model in regulating genetic data processing and argues for a shift toward a harm-based framework. It proposes key reforms, such as the classification of genetic data into categories based on sensitivity, an expanded definition of the data principal to include affected blood relatives, and risk-based processing guidelines that categorize genetic data processing into prohibited, high-risk, medium-risk, and low-risk processing. Additionally, this article advocates for stronger privacy by design and by default requirements, mandatory data protection impact assessments (DPIAs), and the introduction of rights such as data portability and right to restrict processing.
Further, to ensure effective enforcement, it recommends strengthening grievance redressal mechanisms, introducing compensation for privacy harms, and imposing proportionate criminal liability for negligent handling of sensitive genetic data.
By addressing these gaps, this article underscores the need for a strong legal framework that moves beyond notice and consent to provide meaningful privacy protections for genetic data in India’s evolving digital landscape.

Patient’s Right to Consent to Medical Procedures from the Perspective of Health Law, Bioethics, and Human Rights

Patient’s Right to Consent to Medical Procedures from the Perspective of Health Law, Bioethics, and Human Rights
Ni Putu Parvathi Priyadarshini, Gusti Ayu Putri Kartika
Journal of Law Politic and Humanities, March 2025
Abstract
The patient’s right to consent to medical procedures is a vital element in the relationship between patients and healthcare providers, connected to health law, bioethics, and human rights, all focusing on the protection of patient autonomy. This study analyzes the patient’s right to consent from the perspectives of health law, bioethics, and human rights, and identifies challenges in its implementation in Indonesia. A normative method is employed with legislative, conceptual, and comparative approaches. Data is gathered by analyzing national regulations, bioethical principles, and literature on human rights. Descriptive-analytical analysis was used to explore the synergy between these three perspectives in medical consent implementation. Findings reveal that the patient’s right to consent is regulated by Law No. 17 of 2023 and other relevant regulations. Bioethics stresses respecting patient autonomy, while human rights ensure access to information and the freedom to consent. Challenges include paternalistic cultural attitudes, low public awareness, and inadequate healthcare facilities. Recommendations include strengthening regulations, providing bioethics training for healthcare professionals, and educating the public to safeguard patient rights in medical procedures in accordance with health law, bioethics, and human rights.

On the Legal Dilemma and the Way Out of Revocation of Consent by Living Organ Transplant Donors

On the Legal Dilemma and the Way Out of Revocation of Consent by Living Organ Transplant Donors
Jie Xi, Lei Feng
Open Access Library Journal, March 2025
Abstract
This paper’s purpose is to discuss the legal dilemma arising from the revocation of consent by donors in living organ transplantation, analyze its jurisprudential basis and practical impact, and propose a solution to balance the rights and interests of donors and recipients, so as to promote the healthy development of the organ transplantation cause. Through the analysis of typical cases, it reveals the real harm of revocation of consent; combined with the legislative status of China’s Human Organ Transplantation Regulations, it points out the deficiencies of the current law in the definition of conditions, procedures and consequences of the exercise of the right of revocation; from the perspective of jurisprudence, it demonstrates the legitimacy of the revocation of consent, and emphasizes that it is in line with the principle of voluntariness, personal autonomy, and social adaptability of the law; through the comparative study, it compiles the legal difficulties in the protection of donor autonomy, information and notification mechanism, and psychological and social impacts in the US and Germany. Through comparative legal research, the practical experience of the United States and Germany in protecting the autonomy of donors, the information mechanism and the psychological counseling system is examined; specific conditions limiting the exercise of the right of revocation are proposed, including time, form and force majeure factors, and a framework of legislative proposals is constructed based on them.

Editor’s Note: The revocation of consent referred to in this article occurs prior to surgery taking place.

A cross-sectional analysis of the reliability, content and readability of orthodontic retention and retainer informed consent forms

A cross-sectional analysis of the reliability, content and readability of orthodontic retention and retainer informed consent forms
Original Article
Maurice J. Meade, Sven Jensen, Xiangqun Ju, David Hunter, Lisa Jamieson
International Orthodontics, September 2025
Open Access
Summary
Objective
The aim of the study was to determine the reliability, quality and readability of content contained within informed consent forms concerning orthodontic retention and retainers provided by orthodontic treatment providers.
Methods
An online search strategy identified informed consent forms for evaluation. The DISCERN instrument was used to determine content reliability. Each form was assessed for the presence of pre-determined content regarding 11 domains. Analysis for quality of the domain content was via a 4-point scoring scale. The Simple Measure of Gobbledegook (SMOG) and the Flesch-Kincaid Grade-Level (FKGL) were employed to determine readability.
Results
Thirty-four forms satisfied selection criteria. The majority (n = 20; 58.8%) were sourced from websites in the US, with most (n = 22; 64.7%) from specialist orthodontist websites. The mean (SD) DISCERN score per form was 31.9 (4.5). The mean (SD) number of domains present within each form was 7.76 (1.65). The mean (SD) number of points scored per form was 14.82 (3.01) from a maximum of 33. Information regarding retainer review and relevant potential impacts on quality-of-life was lacking and scored poorly. The requirement for lifetime retention was stated in 25 (73.5%) forms. Forms sourced from specialist orthodontist websites scored higher (P = 0.016) than those sourced from general dentist and multi-disciplinary clinic websites. The median (IQR) SMOG and FKGL scores were 10.11 (9.55) and 9.95 (9.18) respectively.
Conclusions
The reliability and quality of the informed consent forms concerning orthodontic retention and retainers was generally poor. The readability of the forms failed to meet recommended guidelines, meaning that many are likely not to comprehend the information provided.

Permission to Die? The Conflict of Consent in Brain Death Testing

Permission to Die? The Conflict of Consent in Brain Death Testing
Karrah St. Laurent-Ariot, George Clement, Bailey Brislin, Paul Zimmerman, Laura Hanson
Journal of Pain and Symptom Management, May 2025
Outcomes

  1. Understand the ethics and laws regarding brain death testing.
  2. Understand processes of brain death testing in ventilated patients and how these interact with patient and family values.

Key Message
Brain death testing can be inconsistent with patient’s cultural beliefs. While consent is not required to evaluate for brain death, apnea testing for a ventilated patient is an involved process which can be traumatic for families. Moral distress can be reduced by using thorough communication early on to establish a care plan that incorporated her spiritual and cultural beliefs.
Abstract
While there is ongoing debate about the need for consent for brain death testing, American Academy of Neurology guidelines state there is “no obligation to obtain consent”. However, familial objection to brain death testing can present care teams with unique challenges.
Case
An 18-year-old woman was found unresponsive after going to sleep with a severe headache. Evaluation at a local hospital showed respiratory arrest triggering intubation, GCS 3, unresponsive pupils, and hypothermia; CT head demonstrated a large intracranial hemorrhage and evidence of brain herniation. She was transferred to a tertiary medical center where brain death testing was recommended once hypothermia resolved. Her father was initially amenable, but after consultation with faith leaders, declined apnea testing, the remaining step to diagnose brain death. Her hospitalization was complicated by substantial barriers to trust and communication. Her family recounted inconsistent information and policies, over-adherence to algorithms, and shades of historical manipulation of minorities. They employed video surveillance and threats of litigation and requested transfer to New Jersey where brain death criteria are not endorsed. Ultimately, the patient received tracheostomy and PEG and was discharged to a long-term acute care hospital.
Discussion
Apnea testing for a ventilated patient can be traumatic for families. Both the family and the medical team experienced immense moral distress which may have been ameliorated by early and thorough communication to establish a care plan that incorporated her spiritual and cultural beliefs. Only one state in the U.S, New Jersey, allows for religious exemptions to Death by Neurologic Criteria under its Declaration of Death Act. It is often helpful to let family witness serial neurological exams to better understand the condition of their loved ones. Lastly, incorporating palliative care and chaplaincy services can decrease moral distress of both families and medical teams.

Editor’s note: We note the reference to the American Academy of Neurology guidelines and it’s apparent treatment of consent, which we will be examining further within our Center for Informed Consent Integrity.

Standardization of written informed consent forms to improve patient care, a quality improvement project

Standardization of written informed consent forms to improve patient care, a quality improvement project
Jaweria Akram, Madeha Khalid, Rawand Abdelnaser Jebril, Isra Saleh Alsheikh, Amina Bougaila, Esha Subhash, Muhammed Zahid
BMJ Open Quality, 23 April 2025
Open Access
Abstract
Background
Informed consent taken by inadequately explaining the procedure to the patient or patient representative, along with incomplete documentation of the process, can have ethical, legal and administrative implications. We conducted a baseline survey from the patient’s representative admitted to the Acute Medical Assessment Unit (AMAU), Hamad General Hospital (HGH) [Doha, Qatar], and their representatives to assess the level of satisfaction and understanding with the current informed consent taking process for thoracocentesis, ascitic tapping, lumbar puncture, blood, and blood product transfusion. It showed only 64% were satisfied. We conducted a Quality Improvement project to standardize the process of taking informed consent for the above-mentioned procedures in order to improve patient satisfaction from 64% to 80% by December 2021 by providing them with individualized informed consent forms along with patient information template in their preferred language.
Methods
A thorough process mapping showed different factors that can lead to inadequate informed consent. We introduced the use of individualized informed consent forms for each above-mentioned procedure with the already printed complications along with patient information template in their preferred language with pictorial presentation of the procedure. Ten Plan/Do/Study/Act (PDSA) cycles were conducted with each cycle lasting four weeks. Before each cycle, the quality team conducted extensive training sessions for the residents and nurses. Different reinforcements were provided with each cycle to ensure the utilization of the interventions.
Results
After 10 PDSA cycles, the level of satisfaction with the process of taking informed consent improved from 64% to 94%.
Conclusion
A standardized informed consent form, along with a patient information template written in their preferred language, improves patients’ understanding to make a well-informed decision and therefore improves their satisfaction with the process, acting as a marker of quality improvement.

Legal Implication in Utilizing Automated Robots: A Written Informed Consent Form Proposal

Legal Implication in Utilizing Automated Robots: A Written Informed Consent Form Proposal
Maria Teresa Contaldo, Sonia Triggiani, Giacomo Vignati, Daniele Bracchi, Gianpaolo Carrafiello
International Journal of Medical Robotics and Computer Assisted Surgery, 22 April 2025
Abstract
Background
Robotic systems enhance physicians’ capabilities by replicating hand movements in real‐time, ensuring precise control and a quick return to conventional procedures if patient safety is compromised. Physicians performing robot‐assisted procedures bear ultimate responsibility, sharing potential liability with manufacturers for malfunctions.
Methods
This study, conducted by a transdisciplinary team of interventional radiologists and a legal expert, evaluates the integration of robotic systems in interventional radiology through a comprehensive literature review, addressing potential legal contingencies.
Results
This paper aims to define liability in this context and examines how workflows and doctor‐patient relationships might be reshaped: patients must be informed about treatment options, including details about robot‐assisted procedures and associated risks.
Conclusions
These systems could significantly impact interventional radiology practice. A dedicated informed consent process is necessary to ensure clear communication and protect the decision‐making process and patient‐centred care; thereby, an informed consent is proposed to comprehensively address these needs.

Informed Consent Practices for Publication of Patient Images in Dermatology Journals

Informed Consent Practices for Publication of Patient Images in Dermatology Journals
Toluwani Taiwo, Bianca Obiakor, Sarah McClung, Kanade Shinkai
JMIR Dermatology, 18 April 2025
Introduction
Clinical images play an important role in informing clinical care and education in dermatology. Standardized informed consent for publishing patient images is an important concern regarding patient privacy, especially given increasing avenues for dissemination (eg. online publication and social media). Protecting patient privacy is a critical aim for dermatologists, as publishing images with potentially identifiable features is often necessary. Establishing trust between dermatologists and patients is imperative when complete anonymity cannot be guaranteed. Clear guidelines and thorough consent practices can ensure that authors are accountable for upholding patients’ privacy and are transparent when obtaining photo consent, thereby empowering patients to make informed decisions about sharing their images. This study assesses current informed consent practices in image publication for top dermatology journals, examining author-facing guidelines and patient consent forms.

Rethinking the Burden of Traditional Informed Consent Prior to Prenatal Genetic Screening

Rethinking the Burden of Traditional Informed Consent Prior to Prenatal Genetic Screening
Megan Allyse, Kirsten Riggan, Natasha Bonhomme, Marsha Michie
Hastings Center Report, 17 April 2025
Abstract
The ethics literature and professional guidelines call for extensive discussions prior to prescreening consent to prenatal cell-free DNA screening to, theoretically, allow patients to make decisions that match their values and goals of care. Most patients, however, actively avoid in-depth moral deliberation when consenting to prenatal screening and then receive a screen-negative result, suggesting that an information-heavy process is irrelevant for average-risk pregnancies. In addition, extensive information-based consent procedures are not feasible in many resource-limited contexts. Meanwhile, patients and families with screen-positive results frequently report minimal support following screening, resulting in long-term distress and suboptimal outcomes. We argue for a fundamental shift to an approach we call “just-in-time consent”: identifying the essential information for values-based decisions prior to screening while relocating resources and moral deliberation to when families receive screen-positive results. This model both ensures that patients and families receive support when they most need it and maintains high standards for the ethical provision of prenatal genetic screening.

Editor’s Note: We recognise that the “just-in-time consent” model proposed in this article could be very problematic. We will be examining this further in our Center for Informed Consent Integrity work.

Challenges in Obtaining Informed Consent for Endovascular Thrombectomy in Acute Stroke: A Survey of Providers

Challenges in Obtaining Informed Consent for Endovascular Thrombectomy in Acute Stroke: A Survey of Providers
Ali Alsarah, Amir Mbonde, Adam Dmytriw, Joshua Hirshch, Aneesh Singhal, Thabele Leslie-Mazwi, Anna Bonkhoff, Natalia Rost, Aman Patel, Michael Young, Robert Regenhardt
Neurology, 8 April 2025
Abstract
Objective
To identify challenges that providers face when obtaining informed consent (IC) for endovascular thrombectomy (EVT).
Background
IC is viewed as integral to medical practice and clinical research, particularly when procedures are involved. However, the process can be fraught with significant challenges, especially for time sensitive emergency treatments such as EVT.
Design/Methods
Healthcare providers involved in acute stroke care were surveyed from July to December 2023. The questionnaire was created using Qualtrics and distributed via institutional networks, professional societies including the American Academy of Neurology and StrokeNet, and social media.
Results
Among 391 total respondents, 74% were staff physicians, predominantly from the United States (70%) and employed at academic medical centers (76%). The mean duration in clinical practice was 13.1 ±10.6 years. When asked how often there was uncertainty regarding the optimal approach to IC for EVT, responses stated: “never” (35%), “sometimes” (52%), “often” (9%), and “always” (4%). Respondents answered “no” (21%), “yes” (56%), or “unsure” (23%), when asked if their institutions had policies around IC for EVT. Furthermore, 83% stated they never received training at their institutions on the topic. In free-text responses about perceived challenges to IC for EVT, several key themes emerged: time constraints in emergency settings (40%), lack of patient capacity (20%), availability of surrogates/family (15%), communication barriers (10%), institutional practices/policies (10%), and legal/ethical considerations (5%). Respondents stated: “time is brain,” “seems excessive like consent for CPR,” “overly ambitious to provide EVT even outside of guidelines,” “wildly different physician opinions,” and “patients are unusually incapacitated.”
Conclusions
This study underscores the provider uncertainty, lack of specific training, and challenges associated with obtaining IC for EVT in acute stroke care. To address these specific challenges, there is a critical need for standardized training, protocols, and guidelines that can be applied across varied geographical regions and multidisciplinary environments.