Roche Diabetes Care and HIPAA Compliance in Medical Device Data

This report examines the data privacy practices of Roche Diabetes Care, specifically focusing on their Accu-Chek Aviva Plus blood sugar monitoring device. The report identifies the types of personal health information collected by the device and analyzes which uses of this data are compliant with the Health Insurance Portability and Accountability Act (HIPAA). The compliant use cases include providing hospitals and pharmaceutical companies with insights into patient populations, while the non-compliant uses involve using data to improve products and services or to market other health-related products directly to patients. The report emphasizes that for Roche Diabetes Care to remain HIPAA compliant, it should conduct its reviews at an individual level, ensuring patient privacy is protected. The analysis is supported by references to relevant literature, and it provides a clear understanding of the implications of HIPAA regulations in the context of medical device data collection and usage.

Running head: REGULATION MEDICAL DIAGNOSTICS 1
Regulation Medical Diagnostics
Student’s Name
Institutional Affiliation

REGULATION MEDICAL DIAGNOSTICS 2
Regulation Medical Diagnostics
Roche Diabetes Care, Inc. is a company that manufactures and supply devices that
monitor the blood sugar of individuals. Over the past 40 years, the company has been helping
diabetic people to track their levels of blood sugar. Being the best provider of health-related
devices, the industry manufactures blood sugar machines and insulin pumps (Gibson, 2018). As
a result, individuals with diabetes have been able to control their health in a better manner.
One of the devices that this company makes is the Accu-Chek Aviva Plus. This machine
measures the levels of blood sugar in individuals. The device is highly preferred in that it
produces accurate results. The meter contains a test strip installed in it. The meter also has a
screen that displays the blood level that is measured on the scale within the meter (Dunne et al.,
2015). The level of blood displayed on the screen reflects the true blood sugar level of a person.
Although this device has been highly rated for its accurate results, some of its uses are
HIPPA compliant while others are not. One of its uses that are HIPPA compliant is the fact that
it is used to provides hospitals and pharmaceutical companies with insights about the patient
population or disease state. This is because hospitals regularly handle people’s health
information and strictly safeguard it within any means.
The uses of the device that fail to comply with the HIPPA requirements include, to
improve their product and services and to market other health-related products and services to
patients. For both of these uses to be applied, the individual’s health information will have to be
exposed to the general public. Thus, privacy will be breached, which is in contrary to the HIPPA
requirements. To ensure that the uses of this device remain HIPPA compliant, Roche Diabetes
Care, Inc. should be conducting its reviews at an individual level.

REGULATION MEDICAL DIAGNOSTICS 3
References
Dunne, N., Viggiani, M. T., Pardo, S., Robinson, C., & Parkes, J. L. (2015). Accuracy
Evaluation of CONTOUR® PLUS Compared with Four Blood Glucose Monitoring
Systems. Diabetes Therapy, 6(3), 377-388.
Gibson, J. (2018). The Roche digital solution to the diabetes challenge. [online] Open Access
Government. Available at: https://www.openaccessgovernment.org/roche-digital-
solution-to-diabetes/45461/ [Accessed 25 Sep. 2019].