Northwestern University Develops Alternative To Drugs For Pain Relief

Northwestern University has recently published a study that details a new device which may present an alternative to opioids for pain relief. The study, reported June 30th, details a new device that is implanted near a patient’s nerves. The device cools down nerves and blocks pain signals from transmitting to the brain.  After an accident or medical procedure results in injury, patients are typically issued several forms of pain relief. These include local injections or various pain relief medications which dull the pain receptors. However, the large-scale provision of these pain relief medications has caused an opioid epidemic resulting in…

FDA Approves Google’s Atrial Fibrillation Detection Device

The Food and Drug Administration has awarded 501k clearance to Verily and iRhythm Technologies for the new cardiac arrhythmia feature on their Zio Watch. The approval comes as wearables continue to become an integral part of healthcare treatment. Wearables can be used to contact others, for navigation, and perhaps most importantly, monitor a user’s health. Google has recognized the potential wearables have to help individuals and encouraged their sister company Verily and iRhythm Technologies to design a wearable capable of competing in the wearables market.  The company created the Zio Watch. The new device works in collaboration with Zio ECG…

MedTronic Awarded FDA Approval For Spine Surgey Planning Platform

Medtronic has recently announced that their spine analyzing planning platform has received FDA 501k clearance. The healthcare technology global leader reported the news on July 14 2022. The UNiD Spine Analyzer v4.0 planning platform includes an artificial intelligence powered algorithm called the Degen Algorithm which helps surgeons to design and personalize procedures for individuals undergoing lower lumbar spine surgery and anticipates spinal compensatory processes 6 months following surgery. In addition, the planning platform will include advancements in predicting spinal alterations in both children and adults.  Degenerative spine disease is a common age-related condition that results in disabilities for individuals all…

Apple Watch Receives FDA Approval For AFib Tracking Feature

The U.S. Food and Drug Administration has given 501k clearance to Apple for a new smart watch feature. The clearance comes as wearables continue to be integrated into healthcare provision. Today, wearables can help measure data related to temperature, blood pressure, blood oxygen, breathing rate, physical movement, and the electrical activity of several organs. Apple has utilized this technology to design a feature which is capable of detecting signs of atrial fibrillation (AFib) in its user.  The Food and Drug Administration approved the Apple Watch as a viable tool for detecting irregular heart rhythms in 2018. Although the Watch’s electrocardiogram…

NIST Issues Revised Guidance For HIPAA Security Rule

The National Institute of Standards and Technology (NIST) has issued its updated healthcare cybersecurity and HIPAA Security Rule guidance to help aid health organizations in safeguarding their Protected Health Information.  The Health Insurance Portability and Accountability Act was introduced to establish national standards for the protection of electronic protected health information that is managed by HIPAA-covered entities. A significant component of the Act is the HIPAA Security Rule, which requires covered entities to implement the appropriate physical, technical, and administrative safeguards in order to ensure the confidentiality, integrity, and availability of the protected health information they maintain. Compliance with the…

HHS Issues Warning Of Web Application Attacks

The Department of Health and Human Services’ Health Sector Cybersecurity Coordinator (HC3) has issued an alert on july 21 about an increase in the number of web application attacks on the healthcare sector. In the alert, the HC3 outlines guidelines to help healthcare organizations to protect their health data against web application attacks. Web applications have become a significant proponent of the healthcare sector in recent years. The software has been utilized for patient portals, maintaining electronic medical record systems, CAD for dentists, remote consultation, predictive analysis, and inventory management. Web applications are accessed through a web browser such as…

CBHA Suffers Major Data Breach From Ransomware Attack

A major behavioral health alliance has recently announced a significant breach of data. The Carolina Behavioral Health Alliance (CBHA) operates in the city of Winston-Salem and is the administer of behavioral health benefits for Wake Forest University and Wake Forest Baptist Medical Center. The attack was discovered by the alliance on March 20, 2022. Upon detection, the organization notified law enforcement and immediately conducted a comprehensive forensic investigation and deduced that cybercriminals had gained access to the organization’s computer systems between March 19 and March 20. The malicious actors potentially viewed and recovered the personal information of approximately 130,000 health…

Study Finds Sepsis Detection Tool Reduces Deaths

Bayesian Health, a machine learning startup has found in collaboration with Johns Hopkins University that a sepsis early detection tool has reduced sepsis associated deaths by approximately 18%. Sepsis is identified as a life-threatening reaction to an infection. It occurs when the immune system overreacts to an infection and creates inflammation. Blood clots and leaking blood vessels occur, and can cause damage to the body’s tissue and organs. Sepsis is extremely common, affecting approximately 1.7 million adults annually. However, despite its prevalence, over 250,000 instances resulted in death. Sepsis is often simple to overlook because its symptoms such as fever…

Smiths Medical Recalls Infusion Pumps After Patient Death

The U.S. Food and Drug Administration has announced that Smiths Medical, a medical device manufacturer, has sent an Urgent Medical Device Correction letter to inform its customers about potential risks associated with their Syringe Infusion Pumps.The letter notified users that the Smiths Medical Medfusion 4000 and 3500 Syringe Infusion Pumps suffer from 8 potential software issues. The devices are used by healthcare providers to deliver blood or blood products, drugs, antibiotics, lipids, enteral feedings and other therapeutic fluids through infusion tubing into a patient’s vein or through other routes of administration. The devices are typically used in neonatal and pediatric…

510(k) Clearance Granted To ResApp Sleep Apnea Detection App

The US Food and Drug Administration has granted clearance to ResApp Health’s 510(k) app. The SleepCheckRx app screens users for moderate to severe sleep apnea by listening to recordings of their breathing and snoring. The regulatory clearance will only apply to the iPhone version. However, ResApp has stated that they are committed to developing an android version.  In the U.S. alone, approximately 20 million American adults live with sleep apnea. Despite the high number, the majority are unaware of their condition. The new app will help provide physicians with the opportunity to evaluate their patients effectively. To acquire access to…

FDA Grants Breakthrough Device Designation To Ventricular Restoration Device

The FDA has awarded Breakthrough Device Designation to Ancora Heart’s Accucinch ventricular restoration system. The device was constructed to help reduce ejection fraction from patients with symptomatic heart failure. It achieves this by restoring the makeup and activity of an enlarged left ventricle. In turn, heart failure symptoms are reduced and the quality of life of patients is improved greatly.  The FDA Breakthrough Devices Designation program was introduced to help patients receive timely access to treatment innovations without compromising their safety. The program helps expedite the development of novel medical devices that have the potential to give more effective treatment…

Concerns Raised Over FDA Cybersecurity Draft Guidance

In April 2022, the FDA published a draft guidance concerning cybersecurity medical devices. The Agency sought to help medical device manufacturers with integrating cybersecurity practices into their products in the premarket period and to help ensure security risks were addressed for the duration of the products lifetimes. The latest update to the guidance included recommendations related to device design and labeling. The FDA also encouraged manufacturers to include threat models, a requirement for a software bill of materials designed to improve data safety and security.   The FDA had created the new draft guidance after receiving concerns on its 2018 guidance….

DHS Issues Fifth Cybersecurity Alert In Five Years to BD’s Pyxis Medication Dispenser

The Cybersecurity Infrastructure Agency, a component of the Department of Homeland Security (DHS), has issued its fifth cybersecurity alert in five years to Becton Dickinson. The medical technology company has received the alerts as a result of vulnerabilities found in their Pyxis automated medication dispensing systems. The Cybersecurity alert is the second alert the medical device manufacturers have received this year. In March, the DHS had identified a vulnerability regarding the use of hard-coded credentials which may allow unauthorized malicious actors to gain access to the file system and use the data for exploitation. The DHS has issued the latest…

FDA Grants Breakthrough Device Tag To Abbott’s DBS System

On July 12, 2022, the FDA awarded Breakthrough Device Designation to Abbott’s deep brain stimulation (DBS) device developed to care for treatment resistant depression (TRD). The Breakthrough Devices Designation program was developed to help patients gain timely access to innovations without putting the patients at risk. The program has helped expedite several innovative technologies that help provide a better quality of life to patients with severe illnesses and diseases. Typically, Abbott’s DBS device is used to treat movement symptoms of patients’ neurological disorders such as Parkinson’s disease and essential tremor. However, recent evidence indicates that the device may be used…

DHS Issues Cybersecurity Alert To Illumina

The Cybersecuirty and Infrastructure Agency, a component of the DHS, has issued a cybersecurity alert regarding Illumina software and its multiple vulnerabilities. The Local Run Manager program provides a complete solution for collecting samples for a run, selecting run parameters, keeping track of progress, examining sequencing data, and reviewing outcomes. The vulnerabilities were identified by Pentest, an information security consultant, who found the softwares diagnostic devices and research-use only instruments were susceptible to security threats. The instruments named included NextSeq 500, 550 and 550Dx, MiSeq and MiSeq Dx, iSeq 100 and MiniSeq. Amongst these devices, Pentest found that an unauthorized…

Study Finds Racial Bias In Faulty Oximeter Readings

The pulse oximeter is a frequently used device to measure oxygen saturation of the blood and the pulse rate. However, the pulse oximeter has been found to overestimate actual oxygenation.The inaccurate readings are typically found in patients identified as a racial and ethnic minority. A recent study published in the JAMA Network, has attempted to determine how inaccurate readings affect patient care.  The study was conducted using a dataset of approximately 3,000 patients who were admitted to the ICU. The oxygenation levels and nasal cannula flow rates were examined for up to 5 days from the date of ICU admission….

Study Finds Wearables Are More Frequent In Cardiac Health Patient Visits

As technology continues to evolve, so too does the individual’s ability to monitor their health. Wearable health technology is rapidly becoming a significant component of the healthcare industry as sensors and artificial intelligence continue to improve. As wearable technology is a relatively new area of health care, there is little information regarding its future use and its place in healthcare provision. Researchers from Massachusetts General Hospital have conducted a study attempting to address the lack of information with wearables and their relationship to cardiac health.  Although wearables can help measure data related to temperature, blood pressure, blood oxygen, breathing rate,…

Wireless Osseosurface Electronic Sensors to Monitor Bone Health

The musculoskeletal system is an area of particular complexity within the study of anatomy. Currently scientists do not understand precisely how a bone heals. Responses can change depending on the individual. As a result, the provision of personalized treatment is challenging. A better understanding of how a bone is healing and responding to treatment enables physicians to tailor treatment according to their patient and will avoid any unintended adverse effects.  Significant advances are taking place as scientists continue to develop bioelectronic interfaces including soft and ultrathin sensors. These tools provide scientists the opportunity to explore and examine unexplored areas of…

Canada Strengthening Privacy Legislation with New Laws

The Canadian federal government is seeking to strengthen their privacy legislation with the introduction of new laws to the House of Commons. The developments to privacy law were introduced in the form of Bill C-27, a renovation of the previously proposed Bill C-11. The objective of Bill C-11 was to repeal the Personal Information Protection and Electronic Documents Act (PIPEDA), the current federal private sector privacy law and replace them with a new legislative framework for data and privacy. However, Bill C-11 was unsuccessful and never made it into law.  Bill C-27 is another attempt to introduce more stringent privacy…

New HHS Cybersecurity Guidelines to Protect PHI

The HHS has published new guidelines for healthcare organizations to improve the protection of the PHI they maintain. In these new guidelines, the HHS will help healthcare organizations to develop a more comprehensive cyber posture. This includes increasing the overall strength of an organization’s cybersecurity, developing protocols for predicting and preventing cyber threats, and improving the ability of the organization to continue operations while responding to cyber threats. A significant portion of breaches of unsecured electronic Protected Health Information are the result of cyberattacks. The HHS has contended that a large percentage of those breaches could have been prevented had…

New HHS Guidelines for Telehealth Providers

The Human and Health Services Department’s Office for Civil Rights has issued new guidelines regarding the use of telehealth technologies for covered health care providers and health plans. Due to the nature of the COVID-19 pandemic, in-person visits from patients to physicians were restricted to only the extremely necessary in order to stop the spread of COVID-19. Because of this, the use of telehealth technologies to deliver health care increased greatly.  While telehealth can expand the access to health care, certain groups of people may face difficulty with accessing telehealth technologies. Populations with limited English proficiency, disabilities, restricted internet access, restricted…

FSMB Updates Telemedicine Policy

Since 2014, there has been a dramatic increase in the utilization of telemedicine, resulting in the advancement of telemedicine technologies and new challenges to the safety of patients. The rapid expansion of telemedicine generated by the public health emergency of the COVID-19 pandemic  has caused concerns regarding fraud and abuse and access inequity. To address these concerns, the FSMB appointed a workgroup tasked with establishing an updated policy regarding telemedicine. The workgroup created the new policy by addressing the challenges and evolving use of telemedicine, analyzing the effect of waiving licensing requirements and practice across state lines, reviewing current state…

COVID Teleheath Cross State Waivers Now Expiring

During the COVID-19 pandemic, all U.S. 50 states were granted emergency authority to waive components of their state licensing requirements.  Under these waivers, states could allow temporary visits from out of state physicians to provide services. However, as the Covid-19 pandemic winds down, waivers allowing for cross-state telehealth are expiring. Hospitals with large amounts of COVID-19 cases were put under immense pressure and had their resources stretched thin. Under the pandemic waivers, overwhelmed hospitals were permitted to request help from physicians in other states to provide care via telehealth. The result of these waivers were extremely advantageous. Particularly to patients…