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

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

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

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

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

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

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

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

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 […]

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 […]

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 […]

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.

Bill Oakley, a writer on "The Simpsons," admitted on Twitter that perhaps the animated TV show did forecast some of our troubling current events.

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

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.

The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.

The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now.

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

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.

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

California DMV will reopen 25 field offices after shutdown

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.

Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66.

Until millions of Americans can be tested weekly for coronavirus, states will walk blindly into restarts. But NIH director has a plan to ramp up.

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.

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.

A federal judge found that the uncertainty surrounding the COVID-19 pandemic was good cause for the delay.

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

Beverly Hills-based William Morris Endeavor said it is reducing its workforce by 20% through furloughs, layoffs and moving people to part-time employees.

Souplantation's owner says there was no way the restaurants' longtime self-serve model could survive in the era of COVID-19

Analysts say steep jump in unemployment and layoffs caused by the pandemic will be hard to reverse quickly.

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

Republicans, once confident of keeping their Senate majority in the fall election, now fear Democrats have a fresh advantage as the coronavirus crisis has reshaped campaigns.

The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America.

It was impossible to maintain any kind of social distance and there was no way to protect oneself from COVID-19.

Trump admits that he's putting Americans at grave risk by encouraging economices to reopen. He should protect us with testing.

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

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.

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.

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

Coronavirus pandemic widens racial and political divisions

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

The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for.

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."

Even as Mayor Eric Garcetti has extended testing to everyone in L.A. County, doing the same for homeless people has proved to be far more challenging.

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