Privacy and Accountability in Black-Box Medicine

Black-box medicine—the use of big data and sophisticated machine learning techniques for health-care applications—could be the future of personalized medicine. Black-box medicine promises to make it easier to diagnose rare diseases and conditions, identify the most promising treatments, and allocate scarce resources among different patients. But to succeed, it must overcome two separate, but related, problems: patient privacy and algorithmic accountability. Privacy is a problem because researchers need access to huge amounts of patient health information to generate useful medical predictions. And accountability is a problem because black-box algorithms must be verified by outsiders to ensure they are accurate and unbiased, but this means giving outsiders access to this health information. This article examines the tension between the twin goals of privacy and accountability and develops a framework for balancing that tension. It proposes three pillars for an effective system of privacy-preserving accountability: substantive limitations on the collection, use, and disclosure of patient information; independent gatekeepers regulating information sharing between those developing and verifying black-box algorithms; and information-security requirements to prevent unintentional disclosures of patient information. The article examines and draws on a similar debate in the field of clinical trials, where disclosing information from past trials can lead to new treatments but also threatens patient privacy

Big data and predictive analytics in healthcare in Bangladesh: regulatory challenges

Big data analytics and artificial intelligence are revolutionizing the global healthcare industry. As the world accumulates unfathomable volumes of data and health technology grows more and more critical to the advancement of medicine, policymakers and regulators are faced with tough challenges around data security and data privacy. This paper reviews existing regulatory frameworks for artificial intelligence-based medical devices and health data privacy in Bangladesh. The study is legal research employing a comparative approach where data is collected from primary and secondary legal materials and filtered based on policies relating to medical data privacy and medical device regulation of Bangladesh. Such policies are then compared with benchmark policies of the European Union and the USA to test the adequacy of the present regulatory framework of Bangladesh and identify the gaps in the current regulation. The study highlights the gaps in policy and regulation in Bangladesh that are hampering the widespread adoption of big data analytics and artificial intelligence in the industry. Despite the vast benefits that big data would bring to Bangladesh's healthcare industry, it lacks the proper data governance and legal framework necessary to gain consumer trust and move forward. Policymakers and regulators must work collaboratively with clinicians, patients and industry to adopt a new regulatory framework that harnesses the potential of big data but ensures adequate privacy and security of personal data. The article opens valuable insight to regulators, academicians, researchers and legal practitioners regarding the present regulatory loopholes in Bangladesh involving exploiting the promise of big data in the medical field. The study concludes with the recommendation for future research into the area of privacy as it relates to artificial intelligence-based medical devices should consult the patients' perspective by employing quantitative analysis research methodology. © 2021 The Author(s