Health Tech Compliance: Patient Data & Safety

Author: Harshit Mishra

Introduction: The health sector of a country plays a decisive role in the GDP (Gross Domestic Product) of the respective country. This sector holds significant importance in the contribution to the development of a country. An effective and good health infrastructure can build healthy nations and ensure continuous growth of nations. There is a popular quote that says, “A healthy mind in a healthy body.” The journey of civilization has faced a lot of ups & downs and evolved gradually; in this whole journey, our past generations have witnessed many of the diseases and pandemics. One of the most recent that we all have faced is COVID-19. With this development, nations are focusing on the construction of effective and functional health infrastructure with the help of technology and innovation. In many of the societies, some diseases are considered social stigmas, for example, leprosy, AIDS, tuberculosis, cancer, etc. Rapid advancement of technologies has given a boost to revolution in health care fields but raised new tension in regard to patient data breach and safety obligations.

Data Privacy in Healthcare: The World Health Organization (WHO) defines healthcare data privacy as the implementation of measures that guarantee the confidentiality, integrity, and availability of patient information. It refers to the protection of sensitive information, including personal records, personal identifiers, and other health-related data of patients, from any kind of unauthorized access, adulteration, misuse, or disclosure. 

Personal Data vs. Medical Data: “Personal data” includes this kind of information, which furnishes the identity of an individual, e.g., name, address, gender, etc. “Medical Data” refers to such kinds of information that are generated during delivery of service regarding healthcare, e.g., diagnoses reports, treatment records, medicinal records, and clinical outcomes.

Although these categories often intersect, medical data is intimately linked to patient care and is subject to additional ethical and professional safeguards imposed by the deontological codes of healthcare providers.

Factors Responsible for Data Privacy Breach in the health sector: The high integration of EHRs and digital tools has acted as a catalyst in the amplification of data breach risks and unauthorized access. There are few real-life examples. 

• The Anthem Inc. breach in the USA, which revealed the ePHI of 79 million individuals.
•  The WannaCry ransomware attack on the UK’s National Health Service (NHS), which disrupted critical healthcare services.
• Similarly, the SingHealth breach in Singapore compromised the personal data of 1.5 million patients.

These examples have played a vital role in highlighting challenges connected with inadequate encryption and resource constraints. These cases clarify that even with established regulations, systemic vulnerabilities and technological shortcomings can undermine data privacy.

Safety measures for prevention of healthcare data privacy breaches: The emergence of technology, especially blockchain & artificial intelligence, provides promising avenues for resolving these kinds of vulnerabilities and inconsistencies. Blockchain technology, which is an operating system and operates as a decentralized and immutable digital ledger. This technology can enhance data integrity and transparency by securely recording transactions and preventing unauthorized alterations. Similarly, AI and machine learning (ML) technologies enable real-time breach detection mechanisms, predictive risk assessment, and automated compliance monitoring systems. 

How Indian law reacts towards the preservation and protection of data privacy: Few Indian laws are discussed below: –

1. Digital Personal Data Protection Act, 2023: This act introduced new compliance requirements for healthcare institutions all over India. All medical data are considered sensitive personal data under the DPDP Act, 2023. Which are enlisted below.

1. Patient Medical Record and Diagnoses
2. Genetic and Biometric Data (e.g., DNA test reports)
3. Medical test report and blood report
4. • Prescription information and medication history
5. Mental health and psychiatric records
6. Severe and communicable disease information (e.g., HIV/AIDS, etc.)
7. Surgical and treatment history

The DPDP act sets out time limits for data retention according to record type with a compliance report. Sec. 3 of the DPDP Act, 2023, deals with the application of the act, which provides for the regulation of digital personal data processing collected in digital form or non-digital form and digitized subsequently in the territory of India or outside India in connection with India.

1. Right to Information Act, 2005: This act empowers citizens to maintain accountability and transparency in government businesses. This act introduced a giving embodiment to the right to know. Provisions deal with data privacy under the RTI Act.

1. Sec. 8 of this act deals with such kinds of information, which are exempted from disclosure. 
2. Sec. 8(e) provides that “information is available to a person in his fiduciary relationship unless the competent authority is satisfied that the larger public interest warrants the disclosure of such information.”
3. Sec 8(j) exempts disclosure of personal information that does not relate to any public activity or interest.

2. Constitution of India, 1949: The Constitution of India facilitates the right to life and personal liberty as a fundamental right under art. 21. The right to privacy evolves as a fundamental right in the ambit of the right to life and personal liberty in consequence of judicial development.
3. Information Technology Act, 2000: This act sets out prominent regulatory principles for ensuring data protection and privacy in cyberspace.

Judicial Pronouncement:

Justice K.S. Puttaswamy (Retd) v. Union of India 2019 (1) SCC 1

In this case the court held that the right to privacy is a fundamental right; “privacy is a concomitant of the right of the individual to exercise control over his or her personality.” The Supreme Court further stated that this right protects the inner sphere of the individual from interference from both state and non-state actors and allows the individual to make autonomous life choices.

Conclusion: In India, a lot of rules and regulations are set out by parliament and state governments for ensuring secure and safe data transactions, such as the Information Technology Act, 2000; Digital Personal Data Protection Act, 2023; Right to Information Act, 2005; etc. But in this era, technologies have taken a crucial place in health care and evolved in a unique form as health tech. The healthcare and health tech fields face challenges related to data privacy breaches of patients. We can overcome these challenges by using artificial intelligence and blockchain technology smartly. In India, the right to privacy is recognized as a fundamental right, so we can’t compromise with the data privacy of citizens in the healthcare and health tech fields as well. We should not be limited only to the establishment of stricter laws but also promote the utilization of artificial intelligence and blockchain technology in the preservation of patients’ data and ensuring safety obligations.