Blog Tag: Wearable Devices

Apple Watch Found to Infringe AliveCor ECG Patents

Apple Watch Found to Infringe AliveCor ECG Patents

AliveCor, Inc., a company focused on cardiac data and remote medicine, successfully convinced an International Trade Commission (ITC) judge that Apple, Inc. infringed multiple AliveCor patents related to electrocardiogram (ECG) technology.  AliveCor asserted that the Apple Watch (Series 6 and 7) infringes multiple AliveCor ECG patents and seeks to ban the watches from importation into the U.S.

In a June 27, 2022 Notice of Initial Determination, an ITC Administrative Law Judge (“ALJ”) agreed with AliveCor, determining Apple had violated Section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337), related to “Unfair practices in import trade.”  The ALJ found the ECG functionality of the Apple Watch Series 6 and Series 7 (pictured below) infringed multiple, valid claims of two AliveCor patents: U.S. Patent Nos. 10,638,941 (titled “Discordance Monitoring”) and 10,595,731 (titled “Methods and Systems for Arrhythmia Tracking and Scoring”).

AliveCor is the complainant in ITC Investigation No. 337-TA-1266 (the “1266 Investigation”), captioned Certain Wearable Electronic Devices with ECG Functionality and Components Thereof.  A public version of the ALJ’s complete Initial Determination should be released soon.  By October 26, 2022, the full ITC is expected to issue a final decision in the 1266 Investigation.  If the Commission affirms the ALJ’s findings, the Apple Watch Series 6 and Series 7 could be banned from importation into the United States.

Best Buy to Acquire Remote Patient Monitoring Company Current Health

Best Buy to Acquire Remote Patient Monitoring Company Current Health

 

Best Buy Co., Inc. announced that it has agreed to acquire Current Health. The deal between the companies is expected to close by the end of Best Buy’s fiscal 2022 fourth quarter.

Current Health is the developer of an AI-powered upper-arm wearable and related software platform that measures a patient’s respiration, pulse, oxygen saturation, temperature, and movement. The real-time measurement device received Class II clearance from the FDA for post-acute care, marking the first time that an end-to-end, passive RPM wearable and platform has received clearance from the agency.

In discussing the agreement between Best Buy and Current Health, Christopher McCann, CEO of Current Health stated:

Over the coming decade, significantly more healthcare can be delivered in the home. We started Current Health to make that exciting transition radically easier for healthcare providers to achieve . . . Best Buy has unparalleled physical reach, world-class supply chain logistics, and trusted support services–allowing us to provide a high-touch consumer experience, at scale. We’re excited to join with Best Buy Health to move safe and effective healthcare into the home globally.

This acquisition will continue Best Buy’s investment in consumer-side health care technologies. For example, Best Buy previously acquired GreatCall Inc. (now Lively Inc.), a personal emergency response subscription service, for $800 million in 2018 and acquired Critical Signal Technologies, Inc., a senior-focused remote patient monitoring provider, for $125 million in 2019. The significant investment into the healthcare technology space for the consumer electronics company follows what Best Buy sees as a major growth opportunity. In a March 2021 earnings call, Corie Berry, CEO of Best Buys, stated, “We plan to invest in people, product development and the ongoing development of our health technology platform and our data analytics and intelligence engines.” Deborah Di Sanzo, President of Best Buy Health, further elaborated by stating:

The future of consumer technology is directly connected to the future of healthcare. We have the distinct expertise in helping customers make technology work for them directly in their homes and by combining Current Health’s remote care management platform with our existing health products and services, we can create a holistic care ecosystem that shows up for someone across all of their healthcare needs.

An example provided in InfoArmor's July 2016 report regarding the type of data hackers were able to obtain

Hackers Steal 600K Records from Health Care Firms – Could Your Wearable Device Be Next?

Security firm InfoArmor published a report in late July 2016 stating that a group of attackers infiltrated American health care institutions, stole at least 600,000 patient records and attempted to sell more than 3 terabytes of that associated data.  In an interview with eWeek, chief intelligence officer Andrew Komarov noted that the hackers he investigated were able to compromise different health care institutions such as private clinics, vendors of medical equipment, and suppliers.  Once inside the compromised systems, the hackers were able to take personally identifiable information and medical data, including imaging data (as shown to the right).

Komarov’s research should come as no surprise in view of a report issued by the Brookings Institute in May 2016 reporting that 23% of all data breaches occur in the healthcare industry.  In fact, nearly 90% of healthcare organizations had some sort of data breach between 2013 and 2015, costing the healthcare industry nearly $6.2 billion.

According to a report done by Bloomberg BNA, while a number of legal mandates exist (e.g. the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology Certification Program, and the Food and Drug Administration’s (FDA) premarket review), the existing guidelines are limited.  Furthermore, medical devices face certain unique cybersecurity pitfalls.  For example, while HIPAA applies to protect health information regardless of where it’s stored, protected health information that exists on disposed of or nonfunctional medical devices can be overlooked.

Connected medical devices (i.e., medical devices that can transmit information through the internet or a networked system) also pose unexpected risks and challenges.  For example, the ability for hackers to remotely access connected medical devices can hypothetically result in significant threats to patient health and safety.  A 2012 episode of the television show Homeland featured a character hacking into and manipulating the pacemaker of the fictional vice president.  While such situations seem far-fetched, in an interview on “60 Minutes,” it was revealed that Vice President Dick Cheney’s doctor had actually disabled the wireless functionality of his heart implant, fearing that it might be hacked in an assassination attempt.

While such fears may seem fueled by paranoia, recent studies have shown that such security threats may be a real concern.  Bloomberg Businessweek reported in November 2015 that the Mayo Clinic engaged a number of high-profile “white hat” hackers to conduct a study of cybersecurity vulnerabilities in their medical devices.  These “white hat” hackers worked on a number of different medical devices, including things such as cardiac monitors, infusion pumps, and hospital beds. In one alarming example, one hacker was able to gain control of an infusion pump – the Hospira Symbiq Infusion System – and was able to remotely cause it to deliver a potentially lethal dose of medication.  Shortly thereafter, the FDA issued a safety notice recommending a recall and the stopped usage of the aforementioned pump.

With increasing concerns about cybersecurity, as discussed on this blog previously, the FDA is currently seeking comment on proposed guidelines that outline when software changes to medical devices would require manufacturers to submit a premarket notification.

Class Action Lawsuit Filed Against Fitbit

Fitbit, Inc., a manufacturer of wearable health technology, is involved in a national class action lawsuit filed on January 5, 2016 in the Northern District of California over two of its wristbands, the Charge HR and the Surge, based on their “PurePulse” LED-based technology used for tracking heart rates.  Generally, the lawsuit alleges that the heart-rate monitor used in those wristbands, advertised under the now amusing tag line “every beat counts,” does not monitor heart beats correctly.  This allegedly especially occurs during times of intensive exercise.

In a statement to ArsTechnica responding to the lawsuit, a Fitbit spokesperson wrote, “We do not believe this case has merit.  Fitbit stands behind our heart rate technology… [b]ut it’s also important to note that Fitbit trackers are designed to provide meaningful data to our users to help them reach their health and fitness goals, and are not intended to be scientific or medical devices.”  Further, Fitbit released another statement after the lawsuit saying that “PurePulse provides better overall heart rate tracking than cardio machines at the gym.”

Fitbit is also involved in another class action lawsuit filed in May 2015 regarding its sleep tracking data, and is also involved in several suits against rival wearable-device maker Jawbone.

Nokia Sensing XCHALLENGE Announces its Competition #2 Winners

Nokia Sensing XCHALLENGE Announces its Competition #2 Winners

The Nokia Sensing XCHALLENGE has announced its Q3 2014 Winners.  According to XPRIZE, a non-profit organization that manages public competitions to advance technological development, the Nokia Sensing XCHALLENGE was offered to accelerate the availability of portable and affordable devices capable of accurately collecting real-time health information.  The Nokia Sensing XCHALLENGE consisted of two distinct competitions: the first was held in Q1 2013 and the second was held in Q3 2014.  The organization states that, through the Nokia Sensing XCHALLENGE competition, it seeks to accelerate the development of continuous monitoring technologies that track the health of the user, particularly for use in developing countries that lack access to affordable, fast, and reliable diagnostic tests.  The competition guidelines focused on whether the entries (1) were relevant to public health needs; (2) advanced sensing technology in a unique and creative way; (3) accurately, reliably, and effectively collected and reported data; (4) were multi-functional and easily integrated with other technologies; and (5) were simple and easy to use for the end user.

XPRIZE recently announced that the Q3 2014 Grand Prize Winner was DNA Medicine Institute (DMI), Inc. of Cambridge, Massachusetts, led by CEO Dr. Eugene Chan.  The company received an award of $525,000.  DMI’s winning devices, including the rHealth X and X1 models (below middle and right) are intended for the ordinary consumer to diagnose various diseases from a single drop of blood.  According to DMI, the devices operate by scanning proprietary diagnostic nanostrips for fluorescence and wirelessly collecting vital signs in real time using an array of sensors that adhere to a subject’s body (the devices can also send the collected data to mobile devices).  According to USPTO records, DMI is the assignee of several pending patent applications generally directed  towards: Multicoded Analytical Nanostrips; Microfluidic Passive Mixing Chip; Flow Based Clinical Analysis; and Capillary Manipulation of Clinical Samples.  DMI is also a finalist for the $10M Qualcomm Tricorder XPRIZE, another competition managed by XPRIZE that seeks to stimulate innovation in the field of consumer diagnostic devices.

The Nokia Sensing XCHALLENGE also announced five additional Distinguished Award Winners that received an award of $120,000, including:

Biovotion of Zurich, Switzerland, led by CEO Dr. Andreas Caduff, created the Vital Sign Monitoring platform, a wearable armband that collects and analyzes data about various physiological parameters and sends the information to the user’s mobile device.

Eigen Lifescience of Stanford, California, led by Dr. Shan Wang, created the Eigen Diagnostic Platform, a device that uses magnetic field sensors to analyze interchangeable diagnostic cartridges to diagnose various diseases from a drop of blood. The information can be transmitted to the user’s doctor using an accompanying mobile device application.

Endotronix Wireless Health Monitoring of Woodbridge, Illinois, led by CEO Dr. Harry Rowland, created a device that monitors heart disease by measuring pulmonary artery pressure using a sensor implanted into the pulmonary artery. An accompanying device wirelessly retrieves pressure data from the sensor and uploads the data to a secure cloud server.