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Preparing Your Data for a Post-COVID-19 World

The US healthcare system’s data infrastructure needs an overhaul to prepare for future health crises, streamline patient care, improve data sharing and accessibility among patients, providers and government entities, and move toward the delivery of coordinated care. With insights from leaders from Arcadia, Validic and McDermott, we recently discussed key analyses and updates on the interoperability and application programming interfaces (API) criteria from the 21st Century Cures Act, stakeholder benefits of healthcare data exchange and data submission facilitation for public health purposes. Click here to listen to the webinar recording, and read on for highlights from the program. To learn more about the “Around the Corner” webinar series and attend an upcoming program, click here. PROGRAM INSIGHTS COVID-19 is reshaping healthcare through technology. Hospitals, clinicians and payors need to use digital health tools to address the challenges of the...

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Blockchain: Health Care’s Next Great Disruptor?

Blockchain is rapidly becoming the focus of conversations regarding health care disruption, and for good reason. What started out as a means for cryptocurrency is now making waves in a variety of industries, set to revolutionize how data is stored and shared. The inability to easily and securely store and share data has long been a burden on the health system. Blockchain poses a solution to that through encryption and highly advanced technological assets which open the doors to health care innovation. Today we see blockchain being used with electronic health records (EHRs) so that a patient’s medical history is easily accessible to him/her, as well as his/her doctors, insurance providers, etc. It’s also providing the “how” in implementing value-based payment agreements, which link payment to performance of a drug or medical device. Blockchain is currently being used both in the private and public sectors, including the FDA and the CDC. While the full...

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ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria

In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health record (EHR) technology (CEHRT). Going forward, ONC will allow health developers to self-declare their products’ conformance with 30 of the 55 certification criteria. ONC will also exercise discretion and not enforce the requirement that certification bodies conduct randomized surveillance of two percent of the health IT certifications they issue. Read “ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria.” Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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Digital Health’s Perfect Storm of Regulators

Both developers and users of digital health solutions face both immense opportunities and daunting challenges. One key challenge is compliance with the often complex state and federal laws and regulations adopted by the numerous regulatory bodies responsible for overseeing different aspects of digital health. The following illustration identifies the numerous regulatory bodies that have been increasingly focused on the use of technology in healthcare and are expected to continue their focus and enforcement activities in the coming years. Because innovation is moving faster than the law in this area, in-house counsel and compliance officers must be prepared to identify and manage the myriad compliance and liability risk considerations arising from participation in and use of digital health tools. This will require an understanding of how each of these regulatory bodies oversees and regulates digital health today and close monitoring of how that evolves and...

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End of Year Attention to Health IT and Digital Health Tools in 21st Century Cures

On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures legislation), which is intended to accelerate the “discovery, development and delivery” of medical therapies by encouraging public and private biomedical research investment, facilitating innovation review and approval processes, and continuing to invest and modernize the delivery of health care. The massive bill, however, also served as a vehicle for a variety of other health-related measures, including provisions relating to health information technology (HIT) and related digital health initiatives.  President Barack Obama has expressed support for the Cures legislation and is expected to sign the bill this month. The HIT provisions of the Cures legislation in general seek to: Reduce administrative and regulatory burdens associated with providers’ use of electronic health records (EHRs) Advance interoperability Promote standards for HIT Curb information blocking Improve patient...

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