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Children and consent under the
Data Protection Act: A Study in Evolution

The Digital Personal Data Protection Act, 2023[1] (“Act”) has, at long last, been past before both houses of Parliament and been published in the official Gazette upon receiving Presidential assent.

The Act is intended to provide legislative expression to the contours of the right to privacy as outlined by the Supreme Court of India in the Puttaswamy Judgements[2] and since then, by other constitutional Courts. The principle, which now stands more or less crystallized, is that the autonomy of a person is inalienably linked to their autonomy over their personal data. Therefore, in a regime which continues to be firmly consent based, the questions of who is a child, who can consent to allowing their personal data to be collected, as well as what can and cannot be done with it, are key to their status as ‘Digital Nagariks’ in years to come.

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Of Consent and Lawful Uses:
Where the Rubber meets the Road

While the concept of consent, in consonance with the current consent based regime under the Information Technology Act, 2000 (“IT Act”)[1] as well as the constitutional primacy of consent and autonomy under various court decisions dealing with the right to information privacy has remained firmly entrenched as the primary basis for collection and processing of personal data under the various drafts of general personal data protection legislation in India over the years,[2] the newly notified Digital Personal Data Protection Act, 2023 (“Act”)[3]also provides for “legitimate use” as key additional basis available to Data Fiduciaries[4] for collection and processing of personal data[5].

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A Fine Balance:
The DPDA and Data Localization

On November 18, 2022, when the Ministry of Electronics and Information Technology (“MEITY”) tabled an entirely new draft Digital Personal Data Protection Bill, 2022 (“Draft”)[1], the concerns around one section, namely Section 17 dealing with cross-border data transfers, were perhaps more pronounced than the shock which accompanied the withdrawal of a long debated previous draft.

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Innovative Medical Devices under the Lens of Clinical Investigations – A Dormant Volcano Waiting to Erupt?

Introduction

Since the advancements in healthcare services and medicinal sciences, medical devices in India have become part and parcel of the existing healthcare delivery services framework.  Medical devices, in essence, are tools, instruments and even software which inter alia enable healthcare service providers to diagnose, monitor, mitigate and treat illnesses and health conditions.

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The National Medical Devices Policy, 2023: A Closer Look at Strategy and Implementation

In an earlier blog post, we took a close look at the National Medical Devices Policy, 2023 (“Policy”), notified by the Department of Pharmaceuticals (“DoP”) on May 2, 2023[1]. We delved into the framework, objectives and core focus areas of the Policy. While the aim of the Policy was clearly to reduce import dependency and establish India as a global manufacturing hub for medical devices, little information was provided on the means to achieve these goals. To draw a holistic picture, we sought guidance from the Approach Paper to the National Medical Devices Policy, 2022 (“Approach Paper”)[2], which was based on similar principles and furthered the same goals as the present Policy. However, the DoP has recently also issued a strategy document on the Policy (“Strategy Document”)[3] to fine-tune and expand on its implementation strategies. In light of the same, this blog post analyses the Strategy Document, measures envisaged thereunder, enforcement priorities and focal points.

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Preparing for the DPDA

PREPARING FOR THE DPDA

In the culmination of a decade long process,[1] the Digital Personal Data Protection Bill, 2023 (“Bill”)[2] was passed before the Lok Sabha on August 7, 2023.

While the important subject matter of the Bill, its long legislative history, and the widely publicised dissents in the Parliamentary Standing Committee[3] portend that it may not pass unchanged, its enactment seems likely within the next few weeks or months.

Further, given its relatively concise nature and, the limited rulemaking and regulatory framework that is needed to enable it, it seems likely that while the Bill will be brought into force in a phased manner,[4] operative portions of it may come into effect relatively quickly.

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Digital Personal Data Protection Bill, 2023

The Digital Personal Data Protection Bill, 2023 (“Bill”)[1] tabled before Parliament on August 3, 2023 is the culmination of a decade long process for evolving general data protection regime for India.

By withdrawing an elaborate, prescriptive draft which was under consideration by Parliament until 2021, to introducing a new, lean, principles based draft for consultation on November 18, 2022 (“Draft”),[2] and then engaging an extensive consultation process which reportedly involved in excess of 20,000 submissions,[3] and several dozen discussions involving personal participation at the highest levels of the Ministry, the Ministry of Electronics and Information Technology has set the stage for the evolution and adoption of a customized and Indian legislation that seeks to find a balance between enabling ease of doing business, and protecting sovereign imperatives and citizens’ rights, which has proved elusive globally.[4]

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Ecommerce Rules

Have you seen this while shopping online?

Hurry- Limited stock available!

Flash deal for 10 minutes only!

Have you been redirected to a download page instead of shutting a popup while playing an online game?

Have you selected food items at a certain price and suddenly noticed addition of delivery fee, packaging fee, partner fee, plus an additional tax just when you check out your cart?

Welcome to the world of dark patterns!

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Liberalisation of Expenses of Management Limits and Linkage with Commission: Impact on the Insurance Industry

Introduction

Pursuant to Sections 40B and 40C of the Insurance Act, 1938 (“Insurance Act”), the Insurance Regulatory and Development Authority of India (“IRDAI”) is empowered to regulate and impose limits on the amount that insurance companies may spend on Expenses of Management[1] (“EoM”). Further, in terms of Section 40 of the Insurance Act, no insurer is permitted to pay, or agree to do so, to any insurance agent or intermediary, commission or remuneration in any form other than in the manner specified by the IRDAI through a regulation.

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Encapsulating the Branded vs. Generics Debate: Pitfalls and Doctors’ Dilemma

The Ministry of Health and Family Welfare, on May 12, 2023, issued an Office Order directing heads of hospitals and polyclinics run by the Central Government, and CGHS wellness centres to ensure that all doctors (including residents) prescribe only generic medicines (“Order”). Additionally, this order contains an instruction to completely curtail the visits of medical representatives to hospital premises, with the caveat that information about new launches may be communicated by way of emails only.

On the face of it, there is little fault to be found in the Order and its dicta. In fact, it ties into the recent push to promote generic medications over expensive branded drugs. That said, it may be worthwhile to take a step back and look at the legal and policy implications of this course of action afresh, especially in light of the unintended consequences it may entail.

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