Unsettled Liability Issues for "Prediagnostic" Wearables and Health-Related Products

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

Holter monitoring is a continuous electrocardiography (ECG) recording that tracks the heart's electrical activity over an extended period, generally 24 to 48 hours. This noninvasive diagnostic tool detects irregular heart rhythms that may not be captured during a standard ECG performed in a clinical setting.DeviceThe Holter monitor is a portable, small device connected to several electrodes on the patient's chest. These electrodes detect the heart's electrical signals and transmit them to the...

The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...

Blood pressure monitoring is a crucial clinical procedure in diagnosing and managing various cardiovascular conditions. Despite its significance, the accuracy of blood pressure measurements can be compromised by multiple factors, potentially leading to either falsely high or low readings. These inaccuracies are critical as they can significantly impact patient care. So, it is vital to understand these challenges deeply and adopt strategic approaches to minimize errors.
Several factors...

Types of Quasi-intentional Torts in Healthcare
Quasi-intentional torts in healthcare involve acts where intent is not directed to harm an individual but results in harm due to careless or reckless speech.

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...