Data Privacy Concerns In Software As A Medical Device (SaMD)
- IJLLR Journal
- 3 minutes ago
- 2 min read
Mrunal Manekar, National Law University Nagpur
Advait Talatule, National Law University Nagpur
ABSTRACT
In the past few years, medical technology, especially “Software as a Medical Device (herein after referred to as SaMD)”, has had a big impact on how healthcare is accessible in India. “Software as a Medical Device” is defined by the International Medical Device Regulators Forum (IMDRF) as medical- purpose software that performs its functions independently of a physical medical device. However, alongside these innovations, there exists concerns regarding data privacy and security. A data breach may expose patient or user data stored on the devices, including confidential information, family history, and sensitive medical history. Healthcare data breaches have been a significant and growing problem for years, with a notable surge in recent months. Data Privacy Regulations related to (SaMD) are stated under the purview of Indian Laws but does not cover the aspect completely hence, it is the need of an hour to bring up robust regulations for proper management of data under Software as a Medical Device. Similarly, in context of medical devices, the handling, collection of patient data raises unique concerns. Compliance to the Medical Device Rules, 2017 and International Standards are essential in ensuring data security and regulatory compliance. Interoperability with EHRs, patient consent ethics, and data ownership further complicate the situation. Wearable devices also come under the ambit of Medical devices that collects user’s data, then uploads it to the cloud or stores it in a computer. This makes the data collected by wearable devices more likely to be attacked or breached. Defects in technology can also cause problems, such as data and privacy breaches. Addressing concerns about data privacy in medical devices and software is necessary to protect people's rights and build trust in the healthcare and technology ecosystems. The paper will delve into the aspect of regulatory compliance in relation to safeguarding data security and privacy while using Software as a Medical Device.
Keywords: Data security, Privacy, Medical devices, Software, Healthcare.
