al COMIC: Hospitals Turn To Alicia Keys, U2 And The Beatles To Sing Patients Home By www.npr.org Published On :: Sat, 09 May 2020 07:00:27 -0400 Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains. Full Article
al 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
al 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
al 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
al New EU Rules for Medical Devices By feedproxy.google.com Published On :: Tue, 12 Jul 2016 20:50:14 +0000 After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading Full Article Life Sciences Practice MDR SRN UDI
al En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers By feedproxy.google.com Published On :: Fri, 15 Jul 2016 16:04:54 +0000 Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1] The en banc opinion...… Continue Reading Full Article Intellectual Property Ben Venue Laboratories CMO MedCo On-Sale Bar
al 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
al 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
al 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
al 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
al 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
al Digital transformation in pharma By worldofdtcmarketing.com Published On :: Fri, 24 Apr 2020 13:32:20 +0000 Full Article Book Review DTC Spending in the news
al Healthcare needs immigrants By worldofdtcmarketing.com Published On :: Mon, 27 Apr 2020 12:02:52 +0000 Full Article in the news
al 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
al 10 Predictions for healthcare By worldofdtcmarketing.com Published On :: Thu, 30 Apr 2020 18:26:56 +0000 Full Article in the news
al Brexit is a fact – now deal with it By medicaldeviceslegal.com Published On :: Thu, 30 Jan 2020 16:36:58 +0000 Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […] Full Article Brexit IVDR MDR
al 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
al 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
al 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
al 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
al 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
al COVID-19 cases higher among San Diego's Latinos; advocates call for more testing By www.latimes.com Published On :: Thu, 7 May 2020 14:16:36 -0400 In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts. Full Article
al California tops 2,500 coronavirus deaths as fears of second wave temper reopening efforts By www.latimes.com Published On :: Thu, 7 May 2020 14:27:21 -0400 Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday. Full Article
al 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
al Axl Rose called Steven Mnuchin an expletive on Twitter, sparking 2020's weirdest feud By www.latimes.com Published On :: Thu, 7 May 2020 16:54:07 -0400 Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat. Full Article
al 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
al Editorial: L.A.'s trails and parks are reopening. C'mon, people, don't screw it up this time By www.latimes.com Published On :: Thu, 7 May 2020 17:15:23 -0400 For goodness sake, if you're going to hike, wear a mask. Full Article
al 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
al 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
al 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
al 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
al 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
al 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
al Letters to the Editor: Old Americans shouldn't have to prove their value to combat ageism By www.latimes.com Published On :: Fri, 8 May 2020 06:00:18 -0400 The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope. Full Article
al Op-Ed: We allowed coronavirus to ravage nursing homes. But there's still time to save lives By www.latimes.com Published On :: Fri, 8 May 2020 06:00:22 -0400 Nursing facilities account for a large percentage of COVID-19 deaths. Better protection and testing can change that. Full Article
al 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
al Remembering a past global struggle in the midst of a present one By www.latimes.com Published On :: Fri, 8 May 2020 06:52:36 -0400 As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe. Full Article
al 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
al 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
al 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
al 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
al All 10 family members in this house got COVID-19. Their patriarch didn't survive By www.latimes.com Published On :: Fri, 8 May 2020 10:00:28 -0400 The Ramirezes never thought the coronavirus would get them. They took every precaution, but the virus still found its way into their home. Over the course of days, each member of the 10-person household became infected. Three were hospitalized. And one, the family patriarch, died. Full Article
al Tens of thousands of California college students to get relief from emergency grants By www.latimes.com Published On :: Fri, 8 May 2020 10:00:34 -0400 California college students will get emergency CARES grants Full Article
al California begins reopening economy as select businesses unlock doors By www.latimes.com Published On :: Fri, 8 May 2020 10:44:55 -0400 Parts of California, including Los Angeles County, are allowing some businesses to offer curbside service Friday. Full Article
al What will concerts look like when California reopens? By www.latimes.com Published On :: Fri, 8 May 2020 11:56:53 -0400 California is slowly reopening, providing hope that you might soon see your favorite artist in concert. But from an arena stage? A computer screen? A drive-in? Full Article
al What's open and closed this busy weekend: Beaches, parks and trails in Southern California By www.latimes.com Published On :: Fri, 8 May 2020 13:44:28 -0400 City and county trails reopen this weekend. Almost every day, the rules change in the beaches and parks of Southern California. Here's the latest. Full Article
al Most California counties fall short of reopening criteria as coronavirus cases climb By www.latimes.com Published On :: Fri, 8 May 2020 13:53:41 -0400 The vast majority of California isn't close to meeting Gov. Gavin Newsom's reopening requirements, a Times analysis finds. Full Article
al Hold the Champagne: Pandemic, recession fears hammer traditional European products By www.latimes.com Published On :: Fri, 8 May 2020 14:49:10 -0400 A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods. Full Article
al California voters asked to vote by mail in November due to coronavirus fears By www.latimes.com Published On :: Fri, 8 May 2020 15:32:02 -0400 Gov. Gavin Newsom ordered ballots be mailed to the state's 20.6 million voters for the November election while imposing new rules for in-person voting. Full Article
al 'You talkin' to me?' Watch Andrew Cuomo's spot-on Robert De Niro impression By www.latimes.com Published On :: Fri, 8 May 2020 15:39:09 -0400 Robert De Niro told Stephen Colbert he wants to play New York Gov. Andrew Cuomo in a pandemic movie. And Cuomo approves. Full Article