Search Results for data security

What you need to know about Germany’s new DiGA fast tracking for health apps

Research2Guidance (R2G) has published a new report on the new, and faster, German regulations for obtaining approval for digital health applications. 2019’s Digital Healthcare Act (DVG) introduced measures to speed up approvals for digital apps so that they can be prescribed by German doctors and reimbursed through German public health insurance, which covers 90 percent of the population. The Digital Health Applications process (DiGA) requires a review by the German Federal Institute for Drugs and Medical Devices (BfArM) to prove that apps and digital tools improve patient care. Other criteria include: Data protection legislation and information security conformance Interoperability CE-certification... Continue Reading

OnePerspective: Covid-19 accelerates digital stroke care for the East of England

...hours of admission, to meet government targets. Early data suggests that this is working well, with positive feedback from both stroke consultants and the stroke specialist nurses. Let’s learn lessons and keep up momentum: Virtual consultations and just one of the many tools that can be used to address healthcare challenges, and it is important to make sure that they are deployed appropriately, safely, and effectively. In ten years, we have learned a lot about IT infrastructure, technology, and its associated governance: we use Visionable because it enables the consultant to see the patient, is user-friendly, and meets IG because... Continue Reading

Mayo Clinic creates AI-powered clinical decision/diagnostics support platform, two digital health portfolio companies

...informed decisions. Mayo Clinic, with partners, is also organizing two portfolio companies to support RDMP: Anumana, Inc. With nference, a synthesizer of biomedical data, Anumana will bring to market digital sensor diagnostics to decipher electrocardiograms (ECGs). The objective is to more effectively spot heart disease at the pre-symptomatic stage, enabling early treatment that saves patients and costs. Their first project will be to develop neural network algorithms based on billions of relevant pieces of heart health data contained in Mayo’s Clinical Data Analytics Platform, including millions of raw ECG signals. nference with Mayo in the past year has released COVID-19... Continue Reading

Good news! Eight software functions no longer classified as medical devices under FDA.

...remove certain software functions from the definition of a device “including software functions that are solely intended to transfer, store, convert formats, or display medical device data and results, including medical images or other clinical information.” The changes apply to software in the following devices and systems: Calculator/Data Processing Module for Clinical Use Continuous Glucose Monitor Secondary Display Automated Indirect Immunofluorescence Microscope and Software-Assisted System Medical Device Data Systems Home Uterine Activity Monitor Medical Image Storage Device Medical Image Communications Device Picture Archiving and Communications System (PACS) Read more in the Federal Register. Hat tip to HISTalk Monday Morning Update... Continue Reading

Short takes 9 April: Doro phones to elderly isolated; funding to Vesta Healthcare, Zedsen; Anthem partners with Canvas EMR, Health Metrics (AU) new owner

...with a physician-targeted EMR, Canvas. Canvas will integrate Anthem member information into their EMR workflows as part of Canvas Payer SDK (software development kit). The company is leveraging this function as in primary care, usually health insurance claims data are a reliable source of patient data. They also gained a brand new Series A of $17 million funded by Inspired Capital and IA Ventures after seed and venture rounds. Becker’s Health IT, TechCrunch And Down Under, Tanarra Capital acquired a majority stake in Health Metrics, a software provider that supports Australia’s residential aged care, retirement living, community, and disability sectors.... Continue Reading

Google’s Care Studio patient record search tool to pilot at Beth Israel Deaconess Medical Center

...patient name, lab results, diagnoses, hospital records, patient names and dates of birth.” Ascension maintained that everything was secure and Google could not use data for marketing or other purposes not connected to the project, but handling was under wraps and Google employees had access to the data. Ascension’s core agreement was about migration of data to Google Cloud and providing G Suite tools to clinicians and employees. But apparently there was also a search tool component, which evolved into Care Studio. Health and Human Services (HHS) Office of Civil Rights, which governs privacy, announced at the time an investigation.... Continue Reading

US Department of Justice decides additional scrutiny needed of $13bn Optum acquisition of Change Healthcare

...and Change comply with the review, unless either the DOJ shortens it or it is extended by the two companies (para. 3). The integration of Change Healthcare into Optum already had significant competitive concerns for DOJ to consider. OptumInsight, Optum’s data analytics unit, and Change provide a similar range of services in health IT and revenue cycle management (RCM). However, Change is one of the largest independent companies providing these services to major providers, with access to the data of 1 out of 3 patients. Optum’s parent, UnitedHealthcare, is the largest US payer. These were the factors that made those... Continue Reading

Deals and news roundup: Ginger’s $100M, myNEXUS to Anthem, Everlywell snaps up PWN, Amwell’s banner year for revenue–and loss, VA reviews Cerner rollout, voice visits for MA, GE’s vScan goes wireless, uBiome founders indicted

...2016. It will become Everly Health Solutions with their testing data kept separate from Everlywell’s. Home Access was PWN’s self-collected lab test company. Everly Health now will support more than 20 million people annually in all 50 U.S. states, Canada, and Puerto Rico. Acquisition terms were not disclosed. PWN’s CEO will take a seat on the Everly Group board to assist integration. Valuation is now estimated at $2.9 bn. Mobihealthnews, Everly release, Bloomberg News And in other news… Amwell reported a Very Good Year in their telehealth services, with visits growing to 5.9 million from 2019’s 1.1 million. Total revenue... Continue Reading

News and deals roundup: AHA opposes Optum buy of Change Healthcare; big raises by Komodo Health, Evidation Health, Ro’s $500M; Appriss acquires PatientPing

...follows their snack-sized January Series D of $44 million (Crunchbase). Komodo feeds their 325 million patient encounter database drawn from EHR, pharma, lab, and government data into their proprietary software for analytics to drive better health outcomes across therapeutic areas. Their primary markets are life sciences and pharma for R&D, clinical trials, and medical affairs. The Series E was led by Tiger Global Management, which earlier this month invested in Tyto Care and Dispatch Health [TTA 4 March], with Casdin Capital plus existing investors ICONIQ Growth, Andreessen Horowitz, and SVB Capital. Release Evidation Health, another data aggregation and analytics company,... Continue Reading

News roundup: Hacks, ransomware of medical records, security cameras spike; Withings launches new mobile-direct devices; Bluestream Health adds Leon Medical (FL) to telehealth

...Oxford University’s Division of Structural Biology. Forbes received the information from Hold Security chief technology officer Alex Holden, who provided screenshots of the hackers’ access to Oxford University systems, and notified the university. The cutely-named DopplePaymer attacked a county government office in Chatham County, North Carolina, and stole residents’ PHI and PII between November 2020 and this past January. Becker’s 10 Feb And on the ‘Someone Got Fired For This One’ list is the response to hacking at Boise, Idaho’s Saint Alphonsus Health System. The health system had a data breach in January. Patients were routinely notified. However, the mail... Continue Reading