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Apple Unveils Electrocardiogram App as Part of New Series 4 Apple Watch

September 12, 2018
by Heather Landi, Associate Editor
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In a move that signals Apple’s ongoing push into digital health, the technology company announced today during its annual fall product event in Cupertino, California that its new Series 4 Apple Watch includes an electrocardiogram function as well as fall detection capabilities.

In a press release issued today, Apple said the Apple Watch Series 4 with watchOS 5 brings “advanced activity and communications features, along with revolutionary health capabilities, including a new accelerometer and gyroscope, which are able to detect hard falls, and an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app, which has been granted a De Novo classification by the FDA (U.S. Food and Drug Administration).”

According to Jeff Williams, Apple’s chief operating officer, it is the “first-ever ECG app offered directly to consumers.” The addition of the ECG app means Apple won’t have to rely on third-party medical devices if the heart rate sensor detects an irregular result.

According to the FDA’s website, the de novo classification option was developed as a regulatory pathway for novel, low-risk medical devices. “The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.” De Novo classification is a risk-based classification process, the FDA states.

According to Apple’s press release, the Apple Watch Series 4 enables customers to take an ECG reading right from the wrist using the new ECG app, which takes advantage of the electrodes built into the Digital Crown and new electrical heart rate sensor in the back crystal. With the app, users touch the Digital Crown and after 30 seconds, receive a heart rhythm classification.

The app can classify if the heart is beating in a normal pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to major health complications, according to Apple. “All recordings, their associated classifications and any noted symptoms are stored in the Health app in a PDF that can be shared with physicians,” the company stated.

CNBC reporter Christina Farr, tweeting live from the Apple event, noted that Williams said the app won’t catch “every instance” of AFib.

One particular concern among cardiologists is whether use of the ECG app will lead to false positives and a rise in the number of "worried well" consumers. Ethan Weiss, M.D., a cardiologist with the University of California, San Francisco, tweeted in response to the Apple ECG app announcement: "I can’t figure out whether today is the best day in the history of Cardiology or the worst."

According to the FDA’s letter of approval for the do novo classification of the ECG app, the ECG app “determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.”

Also, in the letter it states, “The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.” A FDA letter approving the photoplethysmograph analysis software as part of the Apple Watch noted that the feature "has not been tested for and is not intended for use in people under 22 years of age."

The ECG app builds on Apple’s previous work to incorporate heart rate tracking functions into the Apple Watch with a focus on detect arrhythmia and AFib. Last year, the company introduced its new Apple Watch Series 3 with enhanced health and fitness enhancements. The Apple Watch Series 3 included an updated Heart Rate app measuring heart rate during resting, workout, recovery and walking.

During last year’s event, the company also announced the Apple Heart Study, which uses data from Apple Watch to test if the heart rate sensors can detect cardiac arrhythmias, or abnormal heart rhythms, and possibly detect common heart conditions. Apple is currently working with Stanford Medicine on that research study in which the Apple Watch’s heart rate sensor is used to collect data on irregular heart rhythms and notify users who may be experiencing AFib. AFib, the leading cause of stroke, is responsible for approximately 130,000 deaths and 750,000 hospitalizations in the U.S. every year. Many people don’t experience symptoms, so AFib often goes undiagnosed.

According to Apple, the new Series 4 Apple Watch intermittently analyzes heart rhythms in the background and sends a notification if an irregular heart rhythm such as AFib is detected.  It can also alert the user if the heart rate exceeds or falls below a specified threshold.

The Apple Watch’s fall detection function utilizes a next-generation accelerometer and gyroscope, which measures up to 32 g-forces, along with custom algorithms to identify when hard falls occur, the company stated. “By analyzing wrist trajectory and impact acceleration, Apple Watch sends the user an alert after a fall, which can be dismissed or used to initiate a call to emergency services. If Apple Watch senses immobility for 60 seconds after the notification, it will automatically call emergency services and send a message along with location to emergency contacts,” the company said in a press release.

 

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LabCorp Joins Apple Health Records Project

November 5, 2018
by Rajiv Leventhal, Managing Editor
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LabCorp, a provider of clinical laboratory and end-to-end drug development services, has announced that it has enabled Apple’s Health Records feature for its patients.

This iPhone feature aims to make it easier for LabCorp patients to access their LabCorp laboratory test results, along with other available medical data from multiple providers, whenever they choose, according to officials.

In January, Apple announced that it would be testing the Health Records feature out with 12 hospitals, inclusive of some of the most prominent healthcare institutions in the U.S. Since that time, more than 100 new organizations have joined the project,  according to Apple.

LabCorp test results are viewable in the Apple Health app for LabCorp patients who have an account with the company, and enable integration with the Health Records app. In addition to their LabCorp test results, patients will have information from participating healthcare institutions organized into one view, covering allergies, medical conditions, immunizations, lab results, medications, procedures and vitals.

Patients will receive notifications when their data is updated, and the Health Records data is encrypted and protected with the user’s iPhone passcode, Touch ID or Face ID, according to officials.

“LabCorp on Health Records will help provide healthcare consumers with a more holistic view of their health. Laboratory test results are central to medical decision making, and broadening access to this information will help patients take charge of their health and wellness, and lead to more informed dialogues between patients and their healthcare providers,” David P. King, chairman and CEO of LabCorp, said in a statement.

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HIMSS Analytics Introduces Infrastructure Adoption Model for Health Systems

October 25, 2018
by Rajiv Leventhal, Managing Editor
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HIMSS Analytics, the research arm of the Healthcare Information and Management Systems Society, announced the introduction of the Infrastructure Adoption Model, or INFRAM, which is designed to measure the technical infrastructure used within a health system.

The INFRAM focuses on five technical subdomains, allowing organizations to benchmark how their infrastructure operates within the following areas: mobility; security; collaboration; transport; and data center.

Similar to HIMSS Analytics’ well-known Electronic Medical Record Adoption Model, or, EMRAM, the INFRAM is an eight-stage model (0 – 7) that allows healthcare IT leaders to map the technology infrastructure capabilities required to reach their facility’s clinical and operational goals, while meeting industry benchmarks and standards.  The final stage, Stage 7, guides organizations towards optimized information integration, contextualization and orchestration essential for the delivery of higher order local and virtualized care processes.

For reference purposes, Stage 0 on the model represents that an organization does not have a VPN, intrusion detection/prevention, security policy, data center or compute architecture. Stage 3 signifies that an organization has an advanced intrusion prevention system, while Stage 5 represents having video on mobile devices, location-based messaging, firewall with advanced malware protection, and real-time scanning of email hyperlinks.

HIMSS officials note that by identifying specific benchmarks for organizations to reach before they go live with EMR, systems, the INFRAM aims to ensure that a health system’s infrastructure is stable, manageable and extensible. Through this, organizations can ideally improve care delivery and create a pathway for infrastructure development tied to business and clinical outcomes.

 “The INFRAM is a welcome addition to our maturity model suite and addresses a longstanding need – guiding healthcare organizations in securely implementing the infrastructure with which their EMRs are built upon,” Blain Newton, executive vice president, HIMSS Analytics, said in a statement. “We have seen health systems engage with advanced clinical applications, only for them to ‘glitch’ under infrastructure that isn't powerful enough to support their tools. With the INFRAM, healthcare providers can develop a detailed, strategic technology plan that defines their organization's current state, desired future state, and each stage in between to achieve their clinical and operational goals.”

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Clinical Team Communication and Data Access in the Palm of Your Hand

Thursday, October 25, 2018 | 1:00 p.m. ET, 12:00 p.m. CT

Eisenhower Health, a west coast-based Magnet Hospital, implemented an enterprise-wide solution enabling mobile communications and collaboration across all care teams, linking the entire enterprise, advancing its communications capabilities, creating access to an enterprise directory, and improving care team response and turnaround times.

Additionally, the system provided extensive and comprehensive reporting with data analytics showing where and to what extent response improvements were made, but also providing the information the hospital needed to better utilize the system and make adjustments to improve results.

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