The Department of Health and Human Services’ Office for Civil Rights has announced it has published additional resources for mobile health app developers and has updated and renamed its Health App Developer Portal.
The portal – Resources for Mobile Health Apps Developers – provides guidance for mobile health app developers on the HIPAA Privacy, Security, and Breach Notification Rules and how they apply to mobile health apps and application programming interfaces (APIs).
The portal includes a guidance document on Health App Use Scenarios and HIPAA, which explains when mHealth applications must comply with the HIPAA Rules and if an app developer will be classed as a business associate.
“Building privacy and security protections into technology products enhances their value by providing some assurance to users that the information is secure and will be used and disclosed only as approved or expected,” explained OCR. “Such protections are sometimes required by federal and state laws, including the HIPAA Privacy, Security, and Breach Notification Rules.”
The portal provides access to the Mobile Health Apps Interactive Tool developed by the Federal Trade Commission (FTC) in conjunction with the HHS’ Office of the National Coordinator for Health IT (ONC) and the Food and Drug Administration (FDA). The Tool can be used by the developers of health-related apps to determine what federal rules are likely to apply to their apps. By answering questions about the nature of the apps, developers will discover which federal rules apply and will be directed to resources providing more detailed information about each federal regulation.
The portal also includes information on patient access rights under HIPAA, how they apply to the data collected, stored, processed, or transmitted through mobile health apps, and how the HIPAA Rules apply to application programming interfaces (APIs).
The update to the portal comes a few months after the ONC’s final rule that called for health IT developers to establish a secure, standards-based API that providers could use to support patient access to the data stored in their electronic health records. While it is important for patients to be able to have easy access to their health data to allow them to check for errors, make corrections, and share their health data for research purposes, there is concern that sending data to third-party applications, which may not be covered by HIPAA, is a privacy risk.
OCR has previously confirmed that once healthcare providers have shared a patients’ health data with a third-party app, as directed by the patient, the data will no longer be covered by HIPAA if the app developer is not a business associate of the healthcare provider. Healthcare providers will not be liable for any subsequent use or disclosure of any electronic protected health information shared with the app developer.
A FAQ is also available on the portal that explains how HIPAA applies to Health IT and a guidance document explaining how HIPAA applies to cloud computing to help cloud services providers (CSPs) understand their responsibilities under HIPAA.
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