This Week: HHS Modifies HIPPA Fines & Clarifies Tech Liability
This week, the Department of Health and Human Services (HHS) took steps in addressing common concerns among the health tech industry. First, HHS adjusted the monetary penalties imposed on healthcare providers, plans, and business associates–with the lowest annual cap for the least severe violation decreasing from $1.5 million to $25,000. The agency details the penalty tier structure in a notice of enforcement discretion released to the public. Separately, the HHS and the Office of Civil Rights (OCR) released liability guidance regarding the use of third-party apps under the Health Insurance Portability and Accountability Act (HIPAA). Under the new guidance, the OCR explains that when a patient shares protected health information with a third-party app or requests a provider do so, neither the provider nor the health plan would be held responsible under HIPAA, unless the app was “developed for, or provided by or on behalf of the covered entity—and, thus, creates, receives, maintains, or transmits electronic protected health information on behalf of the covered entity.”
FDA Provides Clearance for Cloud-Based Deep Learning Cardiac Arrhythmia Platform
The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics for ECG-based arrhythmia detection. The cloud software product uses deep learning to read and interpret cardiac arrhythmia by collecting single-lead ECG data from a range of FDA-cleared devices. Designed to integrate into a number of different medical devices, RhythmAnalytics interpretations are not intended to serve as the primary diagnosing factor. In a publicly released statement, Dr. Christopher J. McCleod, the clinical director for cardiovascular medicine at the Mayo Clinic remarked “The Biofourmis RhythmAnalytics platform ushers in a new era of computer-aided ECG interpretation — harnessing refined deep-learning techniques that I strongly feel will revolutionize care by improving throughput and reducing costs while maintaining accuracy.”
FDA Launches AI, Blockchain Pilot Program for Food Safety
The Food and Drug Administration has launched a new pilot program that will use artificial intelligence to monitor foodborne illness. The agency is also currently considering implementing a blockchain network to track food. In following with the “New Era of Smarter Food Safety” plan, the FDA plans to utilize advanced technologies including AI and machine learning for the inspection process of imported foods. In the program announcement, the agency explained: “The number of import food lines is increasing year after year, and applying the best predictive and analytical tools will help ensure we’re targeting the greatest risks to protect consumers.” The FDA has planned to hold a public meeting later in the year to discuss food safety, seek stakeholder input, and share ideas on strategy and specific initiatives.
Epic and Cerner Increase Market Consolidation of EHR Industry
A new KLAS report examining the U.S. electronic health record (EHR) market found that both EHR giants Epic and Cerner now make up a combined 85% of market shares among large, 500-bed U.S. hospitals. KLAS attributes the growth to the growing trends of consolidation among hospitals and healthy systems. When hospitals merge, they often integrate all facilities onto a single platform. Among all acute hospitals within the U.S., Epic and Cerner control 54% of the market, with Epic’s hold at 28% and Cerner at 26%. In the report, KLAS noted the likely impact of such trends, “This consolidation—and the desire for easy data sharing—means that acute care EMR purchasing today is less likely to be based on functionality considerations and more likely to be based on factors such as consolidation to a standardized platform or integration with referral organizations.”