y Anti-Vaccination Activists Join Stay-At-Home Order Protesters By www.npr.org Published On :: Sat, 09 May 2020 07:00:57 -0400 Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement. Full Article
y So, You're Not Talking Much In Quarantine. Here's How To Keep Your Voice Healthy By www.npr.org Published On :: Sat, 09 May 2020 07:59:00 -0400 With social distancing, many people are speaking less and their voices sound raggedy. NPR's Scott Simon talks with speech pathologist Sandy Hirsch, about keeping the voice sounding as it should. Full Article
y Tracking The Pandemic: How Quickly Is The Coronavirus Spreading State By State? By www.npr.org Published On :: Sat, 09 May 2020 08:15:27 -0400 View our map and graphics to see where COVID-19 is hitting hardest in the U.S., which state outbreaks are growing the fastest and which are leveling off. Full Article
y Day Three Notes – JP Morgan Healthcare Conference, San Francisco By feedproxy.google.com Published On :: Fri, 15 Jan 2016 18:12:24 +0000 Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies. I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading Full Article Healthcare
y Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry By feedproxy.google.com Published On :: Tue, 19 Jan 2016 17:34:48 +0000 Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading Full Article Biotechnology FDA Intellectual Property Legislation
y PTO Cancer Immunotherapy Fast Track By feedproxy.google.com Published On :: Wed, 06 Jul 2016 16:33:54 +0000 In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative: aims to cut the time it takes to...… Continue Reading Full Article Other National Cancer Moonshot Initiative Patents USPTO
y Looking Forward/Looking Backward – Day 1 Notes from the JPMorgan Healthcare Conference By feedproxy.google.com Published On :: Thu, 12 Jan 2017 19:40:59 +0000 A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week of the annual JP Morgan Healthcare conference in San Francisco, with many thousands of healthcare...… Continue Reading Full Article Medicaid Medicare ASC health plan Medicare Advantage population health management Telehealth
y Food for Thought (and Health): Day 2 Notes from the JP Morgan Healthcare Conference By feedproxy.google.com Published On :: Thu, 12 Jan 2017 19:45:44 +0000 Addressing the Social Determinants of Health: Is the healthcare industry pushing a rock up a hill? We collectively are trying to provide healthcare with improved quality and reduced cost, but the structure of the nation’s healthcare system remains heavily siloed with the social determinants of health often falling wholly or partly outside the mandate and...… Continue Reading Full Article Medicaid Medicare ASC health plan Medicare Advantage population health management Telehealth
y The Old and the New – Day 3 Notes from the JPMorgan Healthcare Conference By feedproxy.google.com Published On :: Thu, 12 Jan 2017 19:47:02 +0000 Day 3 of the JPMorgan healthcare conference was one of striking contrasts between the old and the new. (And, by the way, the rain finally stopped for a day, but it will be back tomorrow to finish off the last day of the conference). The Old: Sitting in the Community Health Systems (CHS) presentation and...… Continue Reading Full Article Medicaid Medicare ASC health plan Medicare Advantage population health management Telehealth
y Notes on Day 4 of the JPMorgan Healthcare Conference By feedproxy.google.com Published On :: Fri, 13 Jan 2017 19:06:20 +0000 Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in holes to achieve scale and full-service offerings. Genesis Healthcare – The largest U.S. skilled nursing facility (SNF) provider, which also is...… Continue Reading Full Article Medicaid Medicare ASC health plan Medicare Advantage population health management Telehealth
y WannaCry Ransomware Alert By feedproxy.google.com Published On :: Mon, 22 May 2017 18:18:24 +0000 This is not a drill. Companies and law enforcement agencies around the world have been left scrambling after the world’s most prolific ransomware attack hit over 500,000 computers in 150 countries over a span of only 4 days. The ransomware – called WannaCry, WCry, WannaCrypt, or WannaDecryptor – infects vulnerable computers and encrypts all of...… Continue Reading Full Article Other cybersecurity ransomware
y Can pharma become a digital industry? By worldofdtcmarketing.com Published On :: Wed, 29 Apr 2020 11:11:33 +0000 Full Article in the news Working in the industry Pharma Digital Transformations
y Gilead games the system By worldofdtcmarketing.com Published On :: Thu, 30 Apr 2020 13:06:27 +0000 Full Article in the news Gilead
y A vaccine probably won’t arrive any time soon. By worldofdtcmarketing.com Published On :: Fri, 01 May 2020 12:10:27 +0000 Full Article As I See It Vaccines
y The MDCG cybersecurity guidance – a helpful rush job By medicaldeviceslegal.com Published On :: Mon, 16 Mar 2020 09:00:42 +0000 It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […] Full Article Cybersecurity Data Protection Software Telemedicine IVDR MDCG MDR risk management software
y New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements By medicaldeviceslegal.com Published On :: Wed, 18 Mar 2020 08:28:42 +0000 I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described. The new guidance The MDCG has […] Full Article Class I Recast Article 120 Blue Guide MDR
y Commission working on proposal to postpone MDR date of application for one year By medicaldeviceslegal.com Published On :: Wed, 25 Mar 2020 20:18:45 +0000 After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […] Full Article Recast Brexit Date of Application IVDR MDR Postponement Swixit Turkxit
y The MDR amendment proposal: more than meets the eye By medicaldeviceslegal.com Published On :: Sat, 04 Apr 2020 20:01:17 +0000 On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […] Full Article Recast Article 59 MDR Brexit Date of Application IVDR MDR Postponement Swixit Turkxit
y MDR amendment proposal article 120 (3) oversight set to be fixed by Council By medicaldeviceslegal.com Published On :: Wed, 08 Apr 2020 11:31:54 +0000 It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […] Full Article Recast Date of Application MDR Postponement
y New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions By medicaldeviceslegal.com Published On :: Wed, 08 Apr 2020 18:53:57 +0000 When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […] Full Article Notified Body Recast AIMDD audits IVDD IVDR MDD MDR notified bodies Unannounced audits
y MDR date of application move: politically a done deal now By medicaldeviceslegal.com Published On :: Sat, 18 Apr 2020 10:31:43 +0000 With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […] Full Article MDR Recast Date of Application Eudamed
y Andy Serkis (and maybe Gollum?) will read 'The Hobbit' for coronavirus charities By www.latimes.com Published On :: Thu, 7 May 2020 14:39:50 -0400 Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday. Full Article
y The Check-In: Justin Turner unsettled at thought of not playing again for the Dodgers By www.latimes.com Published On :: Thu, 7 May 2020 15:01:18 -0400 The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter. Full Article
y Newsom unveils rules governing how quickly California communities can reopen businesses By www.latimes.com Published On :: Thu, 7 May 2020 16:01:33 -0400 Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions. Full Article
y Drive-through celebrations and car parades nixed in Santa Clara County By www.latimes.com Published On :: Thu, 7 May 2020 16:23:40 -0400 The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now. Full Article
y Even if you want to buy a home, it's harder now to get a loan. Or tap home equity By www.latimes.com Published On :: Thu, 7 May 2020 16:46:58 -0400 As the economy has cratered, mortgage lenders tightened standards for people who are still interested in buying or refinancing a home. Full Article
y U.N. nearly triples its coronavirus fundraising goal to $6.7 billion By www.latimes.com Published On :: Thu, 7 May 2020 17:01:11 -0400 The U.N. triples its fundraising target for fighting the coronavirus, even as President Trump plans to freeze U.S. aid to its principal health agency. Full Article
y California to reopen 25 DMV field offices on Friday after they were shut down amid coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 17:44:05 -0400 California DMV will reopen 25 field offices after shutdown Full Article
y 138 employees at Central California meat plant test positive for coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 17:53:51 -0400 Kings County Supervisor Doug Verboon said the outbreak at Central Valley Meat Company in Hanford accounts for nearly two-thirds of the coronavirus cases in the rural county, which has a total of 211 reported cases. Full Article
y Here are the Orange County communities with coronavirus cases By www.latimes.com Published On :: Thu, 7 May 2020 18:09:55 -0400 Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66. Full Article
y Editorial: California was ready for a recession, but nothing could have prepared it for coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 18:33:05 -0400 The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it. Full Article
y San Francisco will allow certain businesses to reopen beginning May 18 By www.latimes.com Published On :: Thu, 7 May 2020 18:51:16 -0400 San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike. Full Article
y Gov. Newsom doesn't see packed stadiums for sporting events anytime soon By www.latimes.com Published On :: Thu, 7 May 2020 19:23:37 -0400 California Gov. Gavin Newsom says he doesn't see full stadiums of fans for sports happening amid the coronavirus outbreak until a vaccine is available. Full Article
y Judge grants request to delay start of prison sentence for former Rep. Duncan Hunter By www.latimes.com Published On :: Thu, 7 May 2020 19:34:43 -0400 A federal judge found that the uncertainty surrounding the COVID-19 pandemic was good cause for the delay. Full Article
y Protesters stage illegal rally at California Capitol to support law enforcement By www.latimes.com Published On :: Thu, 7 May 2020 20:05:42 -0400 Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week. Full Article
y First Californian to get coronavirus in community spread was infected at a nail salon, Newsom says By www.latimes.com Published On :: Thu, 7 May 2020 20:12:17 -0400 Newsom cited the case when asked why personal services, such as nail salons, must remain closed. Full Article
y Coronavirus unemployment: WME cuts 20% of its workforce By www.latimes.com Published On :: Thu, 7 May 2020 20:19:58 -0400 Beverly Hills-based William Morris Endeavor said it is reducing its workforce by 20% through furloughs, layoffs and moving people to part-time employees. Full Article
y Souplantation's buffet-style restaurants closing for good because of the coronavirus By www.latimes.com Published On :: Thu, 7 May 2020 20:49:58 -0400 Souplantation's owner says there was no way the restaurants' longtime self-serve model could survive in the era of COVID-19 Full Article
y Unemployment hits 14.7% in April. How long before 20.5 million lost jobs come back? By www.latimes.com Published On :: Fri, 8 May 2020 06:00:01 -0400 Analysts say steep jump in unemployment and layoffs caused by the pandemic will be hard to reverse quickly. Full Article
y Letters to the Editor: Mr. President, protect us with testing. Then we'll be your coronavirus 'warriors' By www.latimes.com Published On :: Fri, 8 May 2020 06:00:59 -0400 Trump admits that he's putting Americans at grave risk by encouraging economices to reopen. He should protect us with testing. Full Article
y Op-Ed: I see face masks as a socially acceptable fashion opportunity. So should you By www.latimes.com Published On :: Fri, 8 May 2020 06:05:21 -0400 Building a wardrobe of fashionable face masks doesn't make me insensitive to the grave consequences of coronavirus. Full Article
y How to get legally married during the coronavirus crisis By www.latimes.com Published On :: Fri, 8 May 2020 07:00:54 -0400 Marriage, like many aspects of life, has changed. Here's what you need to know about getting a license and the rest of a process that was already complicated. Full Article
y Fears of a second coronavirus surge haunt California as it begins slow-speed reopening of economy By www.latimes.com Published On :: Fri, 8 May 2020 08:00:20 -0400 Reopening California begins -- but very slowly, cautiously and under the shadow of a second wave. Full Article
y An Orange County cafe opened in defiance of Newsom. Now it's the center of stay-at-home resistance By www.latimes.com Published On :: Fri, 8 May 2020 08:00:26 -0400 When it opened last week for the first time since mid-March, Nomads Canteen in San Clemente quickly filled with customers eager to get out of the house and return to some sense of normalcy amid the COVID-19 pandemic. Full Article
y Someday we'll return to the office. It'll be nothing like we've seen before By www.latimes.com Published On :: Fri, 8 May 2020 08:00:35 -0400 With no coronavirus vaccine in sight, employers and building landlords are turning to tech, design and distancing to keep office workers healthy. Full Article
y Column: The cruise ship industry is sinking. I'm OK with that By www.latimes.com Published On :: Fri, 8 May 2020 08:00:54 -0400 Norwegian Cruise Line says it's in danger of going out of business. Maybe that's not the worst thing for an industry of floating petri dishes. Full Article
y At protests, mostly white crowds show how pandemic has widened racial and political divisions By www.latimes.com Published On :: Fri, 8 May 2020 08:00:57 -0400 Coronavirus pandemic widens racial and political divisions Full Article
y Mystery syndrome similar to Kawasaki disease linked to coronavirus at Children's Hospital Los Angeles By www.latimes.com Published On :: Fri, 8 May 2020 09:00:38 -0400 Doctors have recently identified a condition called pediatric inflammatory multi-system syndrome among children who have tested positive for antibodies against COVID-19. Full Article
y Season Interrupted: Middlebury-bound Riley Griffis can hang in the deep end By www.latimes.com Published On :: Fri, 8 May 2020 09:30:27 -0400 Loyola swimming star Riley Griffis quickly read the reality of life outside the pool: 'The time away has shown it's something I need to function." Full Article
y L.A. Phil's 100th birthday bash: Your quarantine must-watch of the day By www.latimes.com Published On :: Fri, 8 May 2020 09:30:59 -0400 It was one of last year's hot tickets: Gustavo Dudamel, Esa-Pekka Salonen and Zubin Mehta, on the same stage at the same time. How to see it for free. Full Article