al

COMIC: Hospitals Turn To Alicia Keys, U2 And The Beatles To Sing Patients Home

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.




al

So, You're Not Talking Much In Quarantine. Here's How To Keep Your Voice Healthy

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.




al

Day Three Notes – JP Morgan Healthcare Conference, San Francisco

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




al

Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

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




al

New EU Rules for Medical Devices

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




al

En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

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




al

Looking Forward/Looking Backward – Day 1 Notes from the JPMorgan Healthcare Conference

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




al

Food for Thought (and Health): Day 2 Notes from the JP Morgan Healthcare Conference

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




al

The Old and the New – Day 3 Notes from the JPMorgan Healthcare Conference

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




al

Notes on Day 4 of the JPMorgan Healthcare Conference

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




al

WannaCry Ransomware Alert

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





al

Healthcare needs immigrants



  • in the news

al

Can pharma become a digital industry?



  • in the news
  • Working in the industry
  • Pharma Digital Transformations

al

10 Predictions for healthcare



  • in the news

al

Brexit is a fact – now deal with it

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 […]




al

Commission working on proposal to postpone MDR date of application for one year

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 […]




al

The MDR amendment proposal: more than meets the eye

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 […]




al

MDR amendment proposal article 120 (3) oversight set to be fixed by Council

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 […]




al

New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

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 […]




al

MDR date of application move: politically a done deal now

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 […]




al

COVID-19 cases higher among San Diego's Latinos; advocates call for more testing

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.




al

California tops 2,500 coronavirus deaths as fears of second wave temper reopening efforts

Los Angeles County, which continues to be the hardest hit area in California, announced 51 additional deaths linked to COVID-19 on Thursday.




al

Newsom unveils rules governing how quickly California communities can reopen businesses

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.




al

Axl Rose called Steven Mnuchin an expletive on Twitter, sparking 2020's weirdest feud

Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat.




al

U.N. nearly triples its coronavirus fundraising goal to $6.7 billion

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.




al

Editorial: L.A.'s trails and parks are reopening. C'mon, people, don't screw it up this time

For goodness sake, if you're going to hike, wear a mask.




al

California to reopen 25 DMV field offices on Friday after they were shut down amid coronavirus

California DMV will reopen 25 field offices after shutdown




al

138 employees at Central California meat plant test positive for coronavirus

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.




al

Editorial: California was ready for a recession, but nothing could have prepared it for coronavirus

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.




al

San Francisco will allow certain businesses to reopen beginning May 18

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.




al

Protesters stage illegal rally at California Capitol to support law enforcement

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.




al

First Californian to get coronavirus in community spread was infected at a nail salon, Newsom says

Newsom cited the case when asked why personal services, such as nail salons, must remain closed.




al

Letters to the Editor: Old Americans shouldn't have to prove their value to combat ageism

The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope.




al

Op-Ed: We allowed coronavirus to ravage nursing homes. But there's still time to save lives

Nursing facilities account for a large percentage of COVID-19 deaths. Better protection and testing can change that.




al

Op-Ed: I see face masks as a socially acceptable fashion opportunity. So should you

Building a wardrobe of fashionable face masks doesn't make me insensitive to the grave consequences of coronavirus.




al

Remembering a past global struggle in the midst of a present one

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.




al

How to get legally married during the coronavirus crisis

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.




al

Fears of a second coronavirus surge haunt California as it begins slow-speed reopening of economy

Reopening California begins -- but very slowly, cautiously and under the shadow of a second wave.




al

At protests, mostly white crowds show how pandemic has widened racial and political divisions

Coronavirus pandemic widens racial and political divisions




al

Mystery syndrome similar to Kawasaki disease linked to coronavirus at Children's Hospital Los Angeles

Doctors have recently identified a condition called pediatric inflammatory multi-system syndrome among children who have tested positive for antibodies against COVID-19.




al

All 10 family members in this house got COVID-19. Their patriarch didn't survive

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.




al

Tens of thousands of California college students to get relief from emergency grants

California college students will get emergency CARES grants




al

California begins reopening economy as select businesses unlock doors

Parts of California, including Los Angeles County, are allowing some businesses to offer curbside service Friday.




al

What will concerts look like when California reopens?

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?




al

What's open and closed this busy weekend: Beaches, parks and trails in Southern California

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.




al

Most California counties fall short of reopening criteria as coronavirus cases climb

The vast majority of California isn't close to meeting Gov. Gavin Newsom's reopening requirements, a Times analysis finds.




al

Hold the Champagne: Pandemic, recession fears hammer traditional European products

A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods.




al

California voters asked to vote by mail in November due to coronavirus fears

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.




al

'You talkin' to me?' Watch Andrew Cuomo's spot-on Robert De Niro impression

Robert De Niro told Stephen Colbert he wants to play New York Gov. Andrew Cuomo in a pandemic movie. And Cuomo approves.