FDA launches the Digital Health Center of Excellence, which will provide expertise and advise FDA on modernizing digital health policies and regulatory approaches.
Bhaku Patel, MSEE, MBA will serve as the first director of the center, which will operate within the Center for Devices and Radiological Health.
HIStalk Announcements and Requests
Welcome to new HIStalk Gold Sponsor Alcatel-Lucent Enterprise. The mission of the Colombes, France-based company is to make everything connect to create the customized technology experience customers need. It delivers on-premise, cloud, and hybrid networking and communications solutions that work for your people, processes, and customers. A heritage of innovation and dedication to customer success has made Alcatel-Lucent Enterprise an essential provider of enterprise networking, communications, and services to over 830,000 customers worldwide. The company has a global reach and local focus with more than 2,200 employees and 2,900+ partners who serve over 50 countries. Thanks to Alcatel-Lucent Enterprise for supporting HIStalk.
I’m about to assess time-outs to overly aggressive PR firm people who keep sending me bulk-emailed pitches for their “story ideas” (apparently unaware that I do not run such “stories” on HIStalk) that ask me to respond if I’m interested, then “circle back” or “just pinging you” a couple of days later when I’ve already conveyed my incuriosity precisely as instructed by not responding. Gmail’s filter rules should work nicely to delete their messages automatically, although without some minor hacking it can’t automatically reply that they’ve been squelched.
September 30 (Wednesday) 11 ET. “The Hidden Threat: New Research on Security Vulnerabilities and Privacy Gaps in Healthcare Apps.” Sponsors: Verimatrix, NowSecure. Presenters: Neal Michie, MEng, director of product management, Verimatrix; Brian Lawrence, direction of solution engineering, NowSecure. The presenters will present research on the security risk profile of 1,000 healthcare apps in managing patient privacy, how they compare to those in other industries, and where the biggest vulnerabilities lie. Attendees will learn how to make their healthcare apps more secure in managing protected health information.
Acquisitions, Funding, Business, and Stock
Carlyle Group will acquire a majority stake in global health research network TriNetX for an unspecific price and valuation.
Teladoc sends a letter to competitor Amwell warning that its digital scope, stethoscope, and some of its telemedicine carts infringe on Teladoc’s patents.
Walmart-owned Sam’s Club offers its members text-based primary care telehealth services through 98point6, expanding a pilot project from last year. Individuals pay $134 per year plus $1 per visit, which is conducted via text messaging through the app of the company, which has 39 doctors.
- Mount Sinai South Nassau selects Infor Cloud Cloverleaf for interoperability that includes API standards such as FHIR.
Behavioral EHR/PM vendor Therapy Brands hires Jessica Kasirsky, DO (NextGen Healthcare) as chief medical officer / VP of regulatory affairs.
Announcements and Implementations
A new KLAS Arch Collaborative report finds that while 25% of nurses report that they are experiencing burnout, EHR satisfaction isn’t a significant cause, and organizations should instead focus on the work environment, employer-imposed bureaucracy, improved teamwork, shared values, and control over schedules.
Decentralized clinical trials software vendor Medable announces GA of a remote consent and re-consent product that allows patients and clinicians to sign up from any location. The company also offers remote patient and site monitoring, telemedicine, and patient engagement tools for clinical outcome assessment.
Optimum Healthcare IT completes virtual Epic training and a go-live at Australia’s Royal Melbourne Hospital.
Cerner will integrate Vynca’s advance care planning system with Millennium to display end-of-life preferences to clinicians and in the patient portal.
Microsoft announces Cloud for Healthcare, a managed service that includes Dynamics 365, Azure, 365, Teams and its new EHR connector, and Healthcare Bot Service for developing self-assessment tools. GA will be October 30.
QliqSoft will offer patient self-scheduling in its virtual care platforms in partnership with Blockit. The company offers the Quincy chatbot as well as its Virtual Visit telehealth solution.
CDC publishes guidance Friday acknowledging for the first time that coronavirus spreads by almost exclusively by air, but then pulls the guidance down Monday in saying that it was posted prematurely before full approval. CDC says it will publish revised guidance soon. The recalled guidance – which says the virus can survive for long periods while suspended in the air and can travel more than six feet — would have had an impact on people (avoiding indoor gatherings, restaurants, and bars), businesses (improved ventilation and and filtration systems), and hospitals (increased use of negative-pressure rooms for infected patients). It would de-emphasize the importance of handwashing and physical cleaning given the low incidence of spread.
Scotland-based infections disease and virology professor Muge Cevik, MD, MSc, MRCP summarizes what we know about coronavirus spread:
- Risk is related to contact pattern (duration, proximity, activity), individual factors, environment, and socioeconomic factors (housing, job security).
- Sustained close contact drives the majority of infections and clusters. Contact with family and friends as well as gatherings create higher risk than brief contact while shopping or in the community.
- Non-household contacts dining together involves especially high risk.
- Transmission is 20 times higher indoors than outdoors, making those beach-shaming media photos pointless.
- Attack rates are highly correlated to symptom severity. Asymptomatic spread is less important.
- Susceptibility increases with age.
- Much of the world’s outbreaks involve nursing homes, homeless shelters, prisons, and meat-packing plants where people share communal spaces for long periods. The largest US clusters have been associated with prisons and jails.
- Lower-paid essential workers are at risk because they cannot isolate, often use public transportation, and are exposed to more people.
- Residents of urban area are at higher risk due to lower incomes, denser living conditions, and a higher proportion of immigrants. Social distancing worked best in more affluent households during the H1N1 pandemic of 2009.
- Viral load peaks require immediate self-isolation as soon as symptoms appear, which will require policies to support that isolation.
Rural hospitals that received federal pandemic aid are afraid to spend the money on COVID-related improvements since the funds were officially in the form of a loan that is due to be repaid this month, with those that aren’t able to repay then having their Medicare payments withheld.
Only 51% of polled Americans would get a COVID-19 vaccine if it were available today, down from 72% in May as people worry that a vaccine will be distributed without adequate testing or with unknown side effects.
CDC tells a federal advisory group that the first people who receive COVID-19 vaccines will be monitored by daily text messages and emails. The 20 million essential workers who are expected to be among the first recipients will be sent daily text messages asking about side effects for the first week afterward, then weekly messages over six weeks.
Sanford Health (SD) is sponsoring a 5,000-attendee, masks-optional October country music concert along with the state’s governor, who previously endorsed the Sturgis motorcycle rally of 500,000 people who have spread infection to an estimated 260,000 new COVID-19 cases. Ticketmaster shows mostly packed spectator sections with no distancing, with the 50% capacity limit being technically accomplished by closing the upper deck while crowding attendees into the lower level. The health system itself – which has 46 medical centers, 210 clinic locations, 233 senior living centers, 158 skilled nursing and rehab facilities, and 48,000 employees — is limiting patient visitors, screening employee and visitor temperatures, mandating social distancing, and requires clinic employees to wear masks at all times.
FDA is reportedly preparing tougher standards for Emergency Use Authorization of COVID-19 vaccines that will require manufacturers to follow participants for at least two months after they receive their second dose, which is likely to push back release until at least December. The requirements will also include having at least five severe cases of COVID-19 in the placebo group, as well as some cases involving older people.
A JAMIA article calls for creating a sub-field of informatics called social informatics, which would drive research on the data, interoperability, and ethical challenges that are involved in integrating social and medical care.
Madison magazine ponders what will happen to the Wisconsin area’s “Epiconomy” when Judy Faulkner leaves Epic. It questions how the foundation to which she will donate her shares will operate within IRS guidelines that require it to distribute 5% of its endowment each year, says the company’s planned return to on-campus work was a “spectacularly bad decision” that may have tarnished the brands of both Epic and Madison in the eyes of the new college graduates Epic hires, and observes that Faulkner does little mentoring and the company doesn’t invest in Madison companies even though its former employees formed several of them. It also notes that Faulkner and her husband donate heavily to liberal political candidates, but Epic has engaged in several legal battles to limit worker rights, such as forcing its employees in its employee agreements to accept binding arbitration instead of filing class action lawsuits. A business professor says that founders who try to “control the [company’s] future from the grave” often mess it up in limiting how much it can think and adjust on its own without them.
Real-time website privacy inspector Blacklight went live today. HIStalk did well with only a couple of traffic counters that I’ve installed but rarely use, but boy is HIMSS.org loaded with questionable stuff, including the Hotjar keystroke tracker. AHIMA’s site, in contrast, is about the same as HIStalk, while CHIME’s gets a perfect score.
Count me out. Airlines are filling seats for “flights to nowhere,” in which people who miss flying so much are buying expensive tickets to board a plane that circles around for a few hours, then lands back at the same airport. I’m personally thrilled to avoid the ever-increasing indignities of American Airlines, including one memorable flight in which my first class upgrade (to avoid AA’s industry-leading cramming of an extra seat in every row of steerage) got me a “lunch” of a few stale triangles of pita orbiting around a sad puddle of hummus. People for whom flying is a fond memory need to get out less.
- InterSystems releases HealthShare CMS Solution Pack to help customers meet the interoperability and patient access final rule that takes effect on January 1.