The Digital Information Security in Healthcare Act (DISHA): Key Aspects and Business Implications

Introduction

The Digital Information Security in Healthcare Act (DISHA) is a proposed legislation by India’s Ministry of Health and Family Welfare (MoHFW) aimed at creating a robust framework for the management and protection of digital health data (DHD). The proposed Act is intended to address concerns related to the privacy, security, and standardization of health data in a rapidly digitizing healthcare ecosystem. With the growing reliance on digital platforms for healthcare services, DISHA proposes to regulate how such data is collected, stored, transmitted, and utilized, focusing primarily on patient consent, data security, and accountability. Although DISHA has not yet been passed into law, its potential impact on businesses especially those in the healthcare sector is significant. Our latest article delves into key aspects of the proposed legislation and how this impacts businesses.

Key Aspects of DISHA

1. Regulatory Framework for Digital Health Data (DHD)

DISHA establishes a comprehensive framework governing the generation, collection, storage, transmission, and use of DHD. The Act mandates strict data protection measures to ensure the security of patient information, applying to all entities processing such data, including hospitals, clinics, insurers, and digital health platforms. DHD encompasses electronic records of an individual’s health details, services received, body part donations, and test results. To comply with DISHA, healthcare organizations must significantly modify their existing data management processes.

2. Consent-Based Data Governance

DISHA establishes a consent-based, patient-centric governance model for digital health information. It mandates that patients must explicitly consent to the collection, use, or sharing of their data, with the right to withdraw consent at any time. Healthcare providers, e-pharmacies, and related businesses will need to adapt their data handling processes to comply, including redesigning intake procedures, modifying data storage systems, and improving communication transparency to ensure patients are fully aware of how their data will be used.

3. Data Security Measures

DISHA mandates robust data security measures, including encryption, access controls, and regular audits, to protect sensitive health information. Healthcare organizations must implement these protocols to prevent unauthorized access to patient data and conduct periodic audits to ensure compliance. To meet these requirements, businesses will need to invest in cybersecurity infrastructure, and staff training, and adopt stringent data protection practices

4. Penalties for Non-Compliance

DISHA outlines specific penalties for organizations that do not comply with its provisions, including escalating fines for repeated violations and potential imprisonment for severe data breaches or unauthorized use of health data. Consequently, organizations involved in collecting and processing digital health data will encounter increased legal risks. Non-compliance could lead to substantial financial penalties, criminal prosecution, and reputational harm. To mitigate these risks, businesses must establish comprehensive compliance programs.

5. Provisions Affecting Digital Health Information Management Systems

Section 30 of the proposed Digital Information Security in Healthcare Bill prohibits the collection of health data solely for the purpose of digitization, which could significantly impact businesses focused on digital health information management. This restriction challenges the fundamental operations of these companies, which typically rely on digitizing health records. Furthermore, the Bill introduces the concept of custodianship, designating entities that collect and process health data as "custodians" with a fiduciary responsibility toward individuals whose data they manage. This fiduciary duty emphasized in Section 35(2), mandates that custodians safeguard patient data diligently. Consequently, businesses must navigate these legal constraints carefully and ensure their data collection practices comply with DISHA, as breaches could result in criminal penalties.

Business Implications of DISHA

1. Strategic? Compliance Investment

Enterprises in the healthcare industry have to invest to ensure compliance with DISHA. This encompasses hiring compliance specialists, implementing permission management systems, and investing in data security technology. While these expenses may represent a significant investment for some organizations, they reflect a necessary commitment to maintaining data integrity and enhancing patient safety.

2. Operational Changes

Businesses managing digital health data will embark on valuable operational upgradation to align with the consent-based governance framework. This will involve refining patient intake procedures, creating effective systems for managing consent, and establishing seamless processes that empower patients to control their data. These proactive adjustments will enhance service delivery and foster a more transparent, patient-centred healthcare environment.

3. Liability Risks

DISHA introduces considerable liability risks for businesses. In addition to financial penalties, organizations that fail to comply with the Act could face criminal charges, including imprisonment for senior management in the case of severe breaches. This makes it crucial for businesses to prioritize data protection and legal compliance.

4. Market Opportunities

While DISHA introduces several compliance challenges, it also creates opportunities for businesses specializing in cybersecurity, data protection, and compliance consulting. Companies that provide solutions for secure data storage, encryption, and consent management are likely to see increased demand as healthcare providers seek to comply with the new regulations.

Legal Solutions for Healthcare Businesses

To effectively navigate the challenges posed by DISHA, businesses in the healthcare sector will need to adopt comprehensive legal and operational strategies. Key solutions include:

a. Data Protection Policies: Businesses should implement robust data protection policies that comply with DISHA’s requirements. These policies should cover all aspects of data handling, including consent management, data security, and breach response protocols.

b. Compliance Audits: Regular compliance audits will be essential to ensure that businesses remain aligned with DISHA’s regulatory framework. These audits should cover both technical and legal aspects of data management.

c. Cybersecurity Infrastructure: Healthcare providers must invest in advanced cybersecurity infrastructure to protect sensitive health data, and ensure contracts with third-party vendors are in place to ensure that all parties meet their data protection obligations under DISHA.

d. Patient Consent Systems: Businesses must develop systems for obtaining and managing patient consent in compliance with DISHA. By incorporating these detailed legal solutions, healthcare businesses can effectively address the challenges posed by DISHA, thereby reducing the risk of non-compliance while enhancing their data security practices? are in place, and ensuring that the organizations not only meet regulatory requirements but also build a robust framework for protecting patient data in a digitized healthcare landscape.