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Home Projects Fabrication Wind turbine jackets off the coast of Rhode Island were engineered in...
Wind turbine jackets off the coast of Rhode Island were engineered in New Orleans and built in Houma
Sam Barnes
Courtesy Gulf Island Fabrication
Market fluctuations are an ever-present reality in the oil and gas industry, which means a company like Gulf Island Fabrication must be quick to respond to new opportunities. After all, its very existence was born out of the oil and gas downturn of the mid-1980s, when co-founders Doc Laborde and Baton Rouge catalog showroom industry magnate Huey Wilson created the Houma company to build offshore oil platforms.
Since those early days, Gulf Island—now headquartered in Houston—has become a leader in the fabrication, maintenance and servicing of structures, facilities and vessels within the energy sector and beyond. With several locations along the Gulf Coast, its craftsmen have built several "first of their kind" structures around the globe.
EXPANDING EXPERTISE: Gulf Island Fabrication's craftsmen have built several "first of their kind" structures around the globe.
So when Gulf Island got the call from Deepwater Wind to assist with the fabrication of the jackets for the country's first offshore windfarm, it jumped at the chance. The company had been watching the fledgling offshore wind market for years, waiting for the right opportunity. Deepwater Wind, a leading U.S. offshore wind and transmission developer, wanted to incorporate Gulf Island's offshore platform capabilities to develop its five-turbine wind farm in the Atlantic Ocean off the coast of Block Island, Rhode Island.
Roy Francis, Gulf Island's senior vice president of business development, says his company began actively pursuing wind farms earlier this decade after recognizing similarities to work it was already doing. A native of Destrehan, Francis came to work at Gulf Island more than 11 years ago.
"We knew that if the industry ever started to take off we wanted to be a part of it," he adds. "We had talked to Deepwater and provided them with budgetary pricing and talked through the constructability of it. We realized that the jackets were quite similar to the ones we were building for platforms in the Gulf."
Ultimately, it proved to be a good diversification move for Gulf Island. "We have the necessary capacity and 32 years of experience building foundations. It was a good interaction and a good customer."
The 30-megawatt wind farm came on line last fall.
Francis says the project came along at just the perfect time—the oil market downturn has significantly impacted the production of new platforms in recent years. "Our numbers are down right now like the rest of the industry."
Bill Blanchard, vice president and general manager of Gulf Island's fabrication group in Houma, says when times are good there are about 450 workers at the facility, but the oil drop hit them hard. "We probably got down to 100 and maybe 60 in the field," he adds. "We have had some relatively large layoffs, but it wasn't to the magnitude that it might have been. We were somewhat successful in placing certain personnel within our other companies."
COLLABORATIVE APPROACH
BORN OF A DOWNTURN: Gulf Island Fabrication was founded in the mid-1980s. Doc Laborde and Baton Rouge catalog showroom industry magnate Huey Wilson created the Houma company to build offshore oil platforms.
In 2015, Metairie-based Keystone Engineering handed off the Deepwater design documents to Gulf Island to begin the fabrication of the foundations, jackets and piles. A strong working relationship with Keystone was key to the project's success—the two companies have collaborated on dozens of projects for 30 years.
"Relationships such as ours are relatively common within the industry, where Keystone knows our pros and cons and strong suits, so to speak, and they are able to adapt the design to suit our facility," Blanchard says.
Throughout the design process, Keystone leaned heavily upon SACS Offshore Analysis and Design software for the design and loading analysis of the structures, while Gulf Island's Lee Barrios, senior project manager, and Richard Rieve, operations manager, participated in early constructability sessions to iron out potential issues with meeting cost and deadline targets.
Designs differed somewhat from a typical oil or gas platform, primarily because of the load exerted by the force of the massive wind turbines. "Most platforms are designed to hold a static gravity load," Blanchard says. "Conversely, wind turbine foundations are designed to support a very long vertical stick that's swaying, with a lot of horizontal and cyclical moments applied to them. So, it takes a completely different jacket stiffening style."
Jacket components were fabricated in assembly line fashion within existing facilities at the Gulf Island yard using a "core group" of workers. At peak, nearly 300 workers were involved in the fabrication of the various components, including pipefitters, welders, sandblasters, scaffold builders and painters.
"From start to finish, you've got a variety of different crafts that are all working on the project in different phases," Blanchard says. "At any given time, you might have the jacket leg components being fabricated as other components are coming out of the pipe mill. You might have piling that's being put together in a separate location, and then the braces being put together. It all gets transferred to the field, where they perform the actual assembly."
The jackets range from 93 to 108 feet tall, with each having its own complexities. "It was more of a serial manufacturing process," Blanchard says. "In general, they were identical, except for a little bit of length added on. There were five jackets, or lower foundations, and five deck sections, which were just an extension of the jacket up to a point above the water line where the mating flange to the turbine was connected."
In the end, there were 10 different component sections, two for each of the five sites. "They were mated together offshore," Blanchard adds.
RHODE ISLAND RIG: The first foundation for Deepwater Wind's turbine is placed off the coast of Rhode Island. Designs differed somewhat from a typical oil or gas platform, primarily because of the load exerted by the force of the massive wind turbines.
Another Louisiana company, Montco Inc. of Galliano, helped assemble the wind farm components from a liftboat after their arrival in the Atlantic. Coincidentally, Montco's boat—normally used for the decommissioning of offshore oil and gas platforms—was also fabricated by Gulf Island.
"It was definitely a step change for us from our normal oil and gas activities in the Gulf of Mexico," says Joe Orgeron, chief technology officer at Montco. Still, it wasn't the first time that Montco has worked "outside the box." Most recently, the company offered its liftboat services to a consortium of European scientists taking core samples in the Atlantic and the Gulf.
"After we were finished working for the scientists, we got picked up by Deepwater Wind," Orgeron says. "Early on, they hired us to do the site-specific cores for the locations where the wind turbines would ultimately be located."
Although another contractor was initially hired to install the foundations and upper deck, the company underestimated the heave and sway of the Atlantic, making it apparent that a liftboat would be the most reliable way to finish the assembly. "They successfully placed the jackets with no problems," Orgeron says. "The problem came when they had to hammer piles through the legs to affix and secure the jackets to the sea floor."
The "pin piles" were nearly 130 feet long.
While there are roughly a dozen liftboat companies operating in the Gulf, none has a boat the size of the one used by Montco. Liftboat "Robert" is the largest currently operating in U.S. waters. When in operation, the boat literally lifts itself out of the water using its legs as support on the ocean floor. In turn, a 500-ton crane mounted on the boat maneuvers and places the jacket components.
Due to the boat's width (137 feet) and leg length (335 feet), Montco was forced to stay in deepwater while in transit to the site, meaning it had to go around the tip of Florida and up the East Coast.
ON THE LINE: Jacket components were fabricated in assembly line fashion within existing facilities at the Gulf Island yard in Houma using a "core group" of workers.
Now that the Block Island Wind Farm is operational, the potential for future offshore projects seems limitless, and as such Gulf Island and Montco hope to continue reaping the benefits. Deepwater Wind, led by a veteran team with extensive experience in developing renewable energy projects, is actively planning offshore wind projects located 15 or more miles offshore to serve multiple East Coast markets, including New York, Massachusetts, Rhode Island and New Jersey.
The company is owned principally by an entity of the D.E. Shaw group, with more than $35 billion in assets.
GE Renewable Energy supplied the five 6-megawatt Haliade wind turbines for the new Block Island wind farm. In addition to the turbines, GE Renewable Energy's offshore wind business is providing long-term services and maintenance for the project. The Block Island Wind Farm is GE Energy Financial Services' second offshore wind investment this year, building upon the company's $12 billion renewable energy investment commitments in more than 18-gigawatts of wind and solar projects.
"Our success here is a testament to the hard work of hundreds of local workers who helped build this historic project, and to the Block Islanders and the thousands more around the U.S. who've supported us every step of the way of this amazing journey," said Deepwater Wind CEO Jeffrey Grybowski in a prepared statement.
The U.S. could add as much as 86,000 megawatts of offshore wind power by 2050, according to the U.S. Department of Energy. If that happens, DOE says it could cut greenhouse gas emissions by 1.8% and support 160,000 U.S. jobs. To fuel the advancement of wind power, a coalition of northeastern U.S. governors recently announced that it would push for the extension of the 30% renewable energy investment tax credit and continue federal research and development efforts.
GULF ISLAND EYES FURTHER DIVERSIFICATION
GOING WHERE THE WORK IS: Gulf Island Fabrication's diversification is not limited to offshore wind farms. Gulf Island also operates a service company and shipyard and is expanding its portfolio of services.
Gulf Island's Francis is quick to point out that his company's diversification is not limited to offshore wind farms. Gulf Island also operates a service company and ship yard and is expanding its portfolio of services. In the process, it will be better able to weather the ebbs and flows of the oil and gas market.
"We do everything from building inland and offshore vessels and barges and repair yards to vessels," he adds. "We have fabrication facilities and we have a company that does service work offshore or onshore (painting, blasting and coastal infrastructure work). While we've traditionally been in oil and gas, we've now diversified to build onshore modules for infrastructure."
Gulf Island recently delivered an onshore module to Trinidad and is currently working on another at its Houma fabrication facilities.
More recently, Gulf Island acquired LeeVac Shipyards, a Covington-based marine fabrication firm with shipyards in Jennings and Lake Charles. Kirk Meche, Gulf Island's president and CEO, said in a statement "the acquisition of the LeeVac assets further diversifies our business, enhances our marine fabrication and maintenance and repair capabilities, and provides our company with facilities in key strategic locations."
This article was originally published in the second quarter 2017 edition of 10/12 Industry Report.
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Hi my name is Steve Boyd, Commercial Director, and when I am not working at BeST I race Rebels Stock Cars around an oval track with around 40 like-minded people all over the UK. My best achievement to date is to win the East Coast Championship in 2013. If you ever go racing come along and say hello.
Aside of being thoroughly dedicated to BeST most days and nights, I am also a keen activist in my spare time. My family and I love nothing more than getting out and about in the great outdoors; exploring new sites and adventures. Camping is one of our favourite pastimes which allows the family to have quality time and partake in outdoor pursuits. Of course this is weather dependant as we have experienced some extreme conditions on the Gower Peninsula. Our new addition to the family is Eric! A 6 month old Beagle with a very mischievous persona. Eric loves walking with his new family and experiencing new sites and smells – He's also a real adventurer! School holidays allowing the family also love to experience foreign travel; our latest adventure being Thailand – an amazing journey!
My name is Tim Bray, I work as a Housing Officer covering the eastern side of the country...my main interest is music... listening, playing & watching it... punk rock is my weapon of choice.
I like coffee, Prosecco, cheese, and yoga. But not necessarily in that order and not at the same time. I get to enjoy two of these in the workplace.
My interests outside of work help me to de–stress. I enjoy socializing with friends in trendy places pretending to be young, with Prosecco of course. This is usually followed by toast with lots of melted cheese to soak up the Prosecco at two in the morning.
To balance out my lively social life, I practise yoga during the week and drink copious amounts of water.
Hello, my name is Andy Bate and when I'm not heading up the Property Operations division within BeST you can find me taking part in local running events and obstacle courses or climbing the mountain ranges of Alicante in Spain. I also enjoy property renovations in my spare time and can often be found cheering on Manchester City and listening to classic rock or regularly attending music festivals. I'm also a keen Sci–fi fan and can be found at local sci–fi and gaming conventions.
My name is Adrian Evans and I currently work in the Housing Department for BeST.
In my spare time I like to play computer/video games and also visit the cinema with friends.
I also enjoy visiting art galleries and producing my own artwork at home.
Hi I'm the Head of Development for BeST Housing.
I enjoy most sports, especially rugby and if the weather is good I'll be out on my favourite toy (pictured).
Hi my name is Eric and my role at BeST is to keep my mum Shelley a little less stressed for the sake of all the staff at BeST. I love going out for walks and getting loads of fresh air but I do hate those silly jogs that I am forced to go on in the rain just to keep her fit.
I wouldn't have got lost in the Maze at singleton as I would have cocked my left leg regularly to aid a speedy exit to the ice cream van (for a non – sweetened ice lolly of course).
Hello, my name is Lewis Wright and my role as an Accounts Administrator. I also have a part time job at Build a Bear Workshop in Trafford Centre as I love the kids that come in and have worked there for over a year now starting as a Summer temp. I like to play football for my football team and go to the gym in my free time as I have a lot of fun doing them both. I love socialising with my friends and always plan to see them as much as I can. However, I am a Liverpool fan so I get slated a lot even though they are the best team in the world.
I am part of the BeST accounts team. When I am not working, I spend most of my free time on my allotment looking after my fruit and veg. This year I have grown potatoes, red and white onions, artichokes, asparagus, various beans and salad leaves. The blackcurrant's and gooseberry's are now in my freezer waiting to be turned into jam.
I have a greenhouse full of tomatoes and chilli plants, there are also two very large cucumber plants. I am a member of the allotment committee and help to raise money for our funds. We turn our old garage into a vintage tea room.
Hello! My name is Matthew Fay and I am the Head of Housing for BeST. A keen animal lover and as you can see from my picture, a Koi Carp Whisperer. I´m very passionate about the arts and love anything to do with music, reading, writing and painting; I am currently learning to play piano, a lifelong dream of mine.
I'm Casey and I work in the maintenance department for BeST.
As well as BeST, I work for Lifeways as a support worker and enjoying spending time with the ladies I support.
I also enjoy spending time with my family and friends. I have an older brother, Chad, he is the funniest person EVER! (when he is in a good mood) Chad has brain damage and learning difficulties but this doesn't stop him from living his BeST life! We love football and both have season cards for Middlesbrough FC. UP THE BORO!!! (see picture: Me, Chad and his friend Shaun).
In my spare time, I like to read and write. I also like to keep active and enjoying cycling and going to the gym. I am also a keen explorer and love to go on adventures. I enjoy going abroad and used to live in America where I studied at the University of Illinois.
In 2011, me and my mam opened a social club (Revo fun nights) for adults with additional needs and it has been running successfully since!
My name is Thomas Murray, Compliance Co–ordinator, and when I am not working for BeST my hobbies consist of betting and watching sports/TV. My favourite sports are UFC, football and horse racing. My favourite TV programme to watch is South Park.
Having been introduced to the public service sector in the early 1990´s, I began as a mentor in a Local Authority Social Enterprise. Whilst gaining further knowledge and experience related to Support and Funding until 2010, I ended my days in the public sector as a Local Authority Finance Deputy. I have spent the last 7 years in the private sector focused on the provision of Supported Housing having had the "BeST" concept thoughts and "lightbulb moment" in 2009.
In my spare time, myself and my wife go swimming at a local health club, we have been building up our strength and stamina over the last 5 months so we can now swim a kilometre a day. We recently challenged ourselves to swim a mile in a day which we achieved and then went home and slept for a couple of hours before Sunday dinner!! We also really enjoy walking together. We often go to Llangollen and other parts of beautiful North Wales to challenge ourselves on foot ….(when its sunny !!). We have 3 children, one of which one has flown the nest to begin his life and his career. Two are still at home and we have enjoyed holidays together abroad and in the UK, we always tend to look for the sunshine though!!
I play the odd round of golf, sometimes I enjoy this, other times this is a walk with some sticks in a bag. More often than not when I play Steve (Pablo) Boyd, who is BeST´s Commercial Director, he takes the £1 …. !!
Hi, I´m Ellen Sherrard and when I´m not working as the Development Assistant at BeST I enjoy napping extensively and spending some time with my cat, family and friends.
My name is Helen, when I am not working at BeST I like to socialise with friends and spending time with my family! I have a young son called Oscar and Chihuahua called Milo.
My free time is spent walking the countryside failing to identify various birds and wild flowers. Holidays usually involve travelling in our old T25 campervan around the UK and mainland Europe.
My name is Liam, I have 3 lovely children Reece (13) Ezra (2) and Caleb (3 months). I'm a big lover of films and video or pc games and most things comic related. I can solve a Rubik's Cube in under 2 minutes, there's usually one on my desk if you need proof. I'm also filled with useless information usually only relevant in a pub quiz.
Hi my name is Georgia. When I'm not working at BeST I enjoy spending time with my cats, Stevie, Flash and Barry. I love family time and going on long walks with my friends!
My name is Timi Adebote (Management Accountant). When I am not working for BeST, as a professional drummer I like to engage myself with sitting on my personal drum set compiling and composing new beats. Active member of the RCCG church choir. This keeps me very busy and occupied.
I am someone with a bubbly personality. Always happy and love to make others happy. I am someone who is a delight to be around and very optimistic.
Hi, my name is Alan and I am the Head of Repairs and Maintenance here at BeST. I have many years experience within the building trade and maintenance. I have worked within the social housing environment some time. I am highly motivated as is my team who ensure we provide an excellent maintenance service to our tenants and customers. Outside of BeST I am a dedicated family man who enjoys the simple thing in life like going to the cinema and theatre and holidaying in warm climates.
Professionally I am responsible for ensuring any repairs or refurbishments to our properties are kept to a very high standard so our customers are happy to call them their home.
In my private time I enjoy fishing primarily for carp and cat fish. My personal best catfish weighed in above 100lb and carp was 34lb but I hope to better this. When not fishing I have a large family with 2 beautiful grandchildren who keep me entertained and busy away from work.
My name is Slavi Genova. I work as a Credit Controller in BeST. I like to spend my free time with my 12 year-old son and read books.
My name is Jay Johal, I have joined BeST as the Housing Officer for the Midlands. I have 2 wonderful sons who try to keep me on my toes. I have worked previously as a Support Worker and Housing Officer with various organisations including local government.
Cooking, listening to music, playing sports, swimming and DIY are just some of the things I enjoy when I get time to myself.
I am from Lithuania originally. I suspect you opened google maps to see where it is. I do not blame you. Fun fact - Gatwick airport have more people traveling in one summer day at the airport than currently living in my country, 2.5 m (minus 1 now I've left to be precise).
I am a Sales Ledger Clerk. Somebody said that my job is boring, but I am passionate about what I do. My husband named me ''Mrs. Talk-a-lot'' after he spent a six hour journey with me and my Aunty in the car. He said there was no space to insert a word into our conversation.
Most of the time I am nice, but I have my ups and downs like everybody else. Love the summer, love the countryside and glamping in our caravan.
I began my employment at BeST on 7th January as Compliance Project Manager, having been attracted to its charity status. I am RoSPA Level 5 Diploma Qualified and a graduate member of IOSH, with over ten years-experience in the strategic implementation of occupational health and safety in a wide variety of industries including logistics, waste management and landfill, warehousing and consultancy services for compliance.
I met my partner James three years ago and between us we have six children (thankfully only my two live with us right now!) five of whom, where born in March. James has three born on the same day!
We love walking and visiting historic places of interest, going to gigs and festivals. We generally drag the children along with us, which they love having been sufficiently indoctrinated into liking the same music! I like to read and collect Booker Prize Winners (not because I am a book snob, but because time is limited, and they are a guaranteed good read!) I also have an unhealthy obsession with Jason Momoa. Too much information…?!
My name is Hannah Mansfield, I am 23 years old. I moved to Greater Manchester around 7 months ago, I am originally from Derbyshire. I decided I wanted a new challenge and a fresh start. I spend a lot of time with my partner, I love to go shopping and socialise with my friends.
My name is Luca, I'm a passionate, optimistic and dedicated person who takes up responsibilities with utmost enthusiasm and see to it that I complete my tasks in time. I've a great amount of perseverance to achieve my goal. My optimistic and planned approach in things I do is what driving me towards my success.
Always loved playing football as well as watching it on TV. Now I play for Urban Bubble in a very competitive business league and me and my team have been achieving great results, I also like to listen to music and socialize.
My name is Romaan, I joined BeST on November 11th 2018 and have loved it ever since. Everyone is truly amazing here and it doesn't feel like you're at work when you're surrounded by family. With my confidence and "heads I win, tails you lose" attitude alongside my driving skills, it shows that I'm a car enthusiast as well as an Accounts Administrator.
I am well and truly an outdoor person, proven by my mum saying "you're never home". From mountain biking to rock climbing to signing my life away deep sea diving, I'm ready to make memories and experience it all. Some of the best memories I've made have been at BeST in such a short period of time, and I'm almost guaranteed loads more to come !!
My name is Patricia Mokhberi and I am Head of Revenue and Benefits (essentially dealing with tenant's rent accounts and rent increases).
Outside of work I am family orientated, and I like to make frequent trips around the UK (where my children live) and to the Netherlands, visiting extended family members. This is particularly important as my passion is genealogy. I have 4500 in my family tree so far and growing. I intend to compile a family history book to leave to posterity. I enjoy travel, gardening, and socialising with friends. The Scottish Highlands, Yorkshire, London and Durham are my favourite places, as I have local connections to these places. Ireland, The Norwegian, Fjords and the US are on my travel list.
My name is Mario Daniel and I joined BeST in October 2018 as a Revenue and Benefits Officer and I have since loved every minute of it. I am a family orientated person, I like to travel and learn about new cultures and meet new people. My hobbies are football, swimming and volleyball. I am interested in politics, policy making and diplomacy.
Hello, my name is William Fay, I have been at BeST several times over the years in the summer months. I am now permanently employed here as the Revenues and Benefits Administrator. I love it here at BeST and I have made many close friends.
I am an avid lover of the outdoors and I am a qualified SCUBA diver, I have dived inside a sunken ship and on a coral reef. I spend most of my time either socializing with my friends and spend most of my time with my best friend which happens to be my girlfriend.


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Murder verdict confirmed
A mixed panel of two EULEX judges and three local judges presided over by a EULEX judge at the Supreme Court rejected the second appeal by the defence council in a murder case, related to a blood feud. It confirmed in its entirety the previous verdicts in the case that sentenced the defendant to twenty-five years imprisonment. This is a final judgment. No appeal is possible.
The case relates to an incident in 2004 in a village of Gjakovë/Ðakovica municipality when two people were shot dead. The incident occurred in revenge for another murder committed in 2000. In August 2005, the District Public Prosecutor in Pejë/Peć filed an indictment charging D.N. with two counts of murder. The indictment was confirmed in October 2008. In June 2009 D.N. was found guilty by the District Court of Pejë/Peć of two criminal offences of murder committed out of blood feud and in a brutal or insidious manner.
Deciding on appeals filed on behalf of the defendant and on behalf of the injured party, the Supreme Court annulled this judgment and returned the case to the court of first instance for retrial. On 15 October 2010, the District Court of Pejë/Peć found the defendant D.N. guilty of two criminal offences of murder committed out of blood feud and in a brutal or insidious manner in violation and sentenced him to twenty-five years of imprisonment. In August 2012 the defence council, appealed this judgment. This appeal has now been rejected.
The case was prosecuted by a local prosecutor from District Prosecution.
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redpajama_set_name: RedPajamaCommonCrawl


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Uber plans self-flying drone taxis to beat city traffic
The Ehang 184, a passenger drone Credit: Ehang
26 September 2016 • 10:32am
Drones (consumer)
If you summon an Uber in 10 years' time, you will probably get a car that drives itself. But then again, you may not be travelling in a car at all.
The taxi-hailing app is working on technology that would allow airborne passenger drones to fly its users short distances around cities, it has emerged, raising the prospect of a future in which skylines are dotted with Uber aircraft shuttling commuters back and forth.
Jeff Holden, Uber's head of product, told technology website Recode that the company is researching "vertical take off and landing" (VTOL) technology. Instead of the helicopter-style rotor blade drones, VTOL aircraft have fixed wings like planes, enabling them to fly silently, while taking off and landing vertically.
Amazon's delivery drones, currently being tested in Cambridgeshire, use a similar technology to cut down on noise and extend their range.
Holden said Uber wanted to "offer our customers as many options as possible to move around" and that the technology could be available within a decade.
"It could change cities and how we work and live," Holden said, pointing out that moving traffic from the road to the air could dramatically cut down on congestion and the time it takes to cross cities. He said he envisages aircraft taking off from and landing on the roofs of buildings.
Uber is already testing driverless cars Credit: AFP
While the idea may seem far-fetched, Uber is not the only one researching passenger drones. Earlier this year Ehang, a Chinese company, unveiled the 184, an autonomous quadcopter drone designed to carry a single passenger, with a battery life of 23 minutes. The 184, which has been slated for release as early as this year, is expected to cost up to $300,000 (£232,000).
Google founder Larry Page is one of the major believers in flying cars, putting $100m of his own money into startups developing the technology.
However, filling our skies with passenger drones within 10 years is an ambitious undertaking, and would require hundreds of pages of new regulations, not to mention consumers who would be willing to put their life in the hands of a small self-flying aircraft. It would also, presumably, be incredibly costly to develop.
But Uber is already at the forefront of developing self-driving technology. Earlier this month it began testing a driverless car service in Pittsburgh.
Crazy futuristic transport


Discussion in 'Currently broadcasting & New Lakorn' started by Bitter Kisses, Nov 20, 2018.
(Our love, in the day with no existing memory) - The literal Thai translation.
@xcinsationalx is this the same one???
Camilla is so tiny. She is not the best actress but for some reason I like watching her.
Hey, just want to ask is this a remake of Tono and Aim lakorn " Bu-Ngah Nah Fon" I see on IG saying they just change the title but it's a remake of the lakorn. Anyone know?
Woo New Year dramas. Don't disappoint me!
This is airing on February 1st.
@dancy No idea, but I've seen that to!
The first episode was good, I liked it.
Its 2 ep per week cause its replacing Nakark Keaw. Friday and Saturday slot.
Camilla looks really familiar. Is she a Miss Thai or something?
Is this like the remake of the korean drama Save the last dance starring Jisung and Eugene. The story seems very similar to that.
First attack on his life..looses memory, meets and falls in love with the girl. Second attack...gains his memory and forgets the girls and goes back to his old life. The girl comes looking for him but when he doesn't recognizes her, she starts working at his office to stay close to him.
Thats Oab??? He looks so mature and tall and stuff. I was just rewatching some scenes of spike...he looks so different here.
So does this mean he will no longer do BL??
Oab be lookin fine lol. But I'm not going to continue watching this. Story too predictable.
She debuted in a ch7 lakorn with her sister Nikki. They played twins. P'eks were Tle Thanapol and Vee. I forgot the title of the lakorn though.
The plot is so depressing sounding... I despise amnesia so much. Too bad, because they look like they have onscreen spark.
72701 and spanky like this.


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Selected filmmakers are required to attend the festival April 5-6, 2019 and speak about their work. Selected films will be shown at all three festival screenings.
Selected filmmakers will receive a $1,000 honorarium. Young filmmakers will receive a $250 honorarium.
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Governor Ásgeir Jónsson's Revolt
Hallur Hallsson 12. December 2021 ArticlesAuthorsBusinessCapital AreaDowntown ReykjavikIcelandic Times - Issue 45Icelandic Times – Issue 45Magazine IssuesMagazinesNewsPostcode 101ReykjavíkZIP CODES
Iceland's Central Bank has never been better equipped to ensure stability to serve the people, claims Governor Ásgeir Jónsson. With the merger of The Bank and Financial Supervisory at the start of 2020, the Bank is stronger than ever to enforce discipline on financial markets to improve the welfare of the people.
By Hallur Hallsson. Photo: Páll Stefánsson
Dr. Ásgeir Jónsson was appointed Governor of Iceland's Central Bank in July 2019, at 49 years of age. His appointment is for five years, so he has three more years to serve. "What will be, will be regarding a second term", he says. His emphasis is to establish the Bank's independence. His background is different from many of his predecessors; there was no politicking for his appointment. He has been called a communist and a liberal but has never been active in politics. However, he has made his stance clear on many issues that the Bank has to deal with.
Ásgeir Jónsson's forefathers were farmers and fishermen and he, himself, was a fisherman aboard trawlers from the town of Sauðárkrókur in the North—and never got seasick! However, though Dr. Jónsson is the Bank Governor, the highest office that an economist can attain to, he faced extreme challenges as a child: stammering, illiteracy and bullying. He was raised, until he was eleven years of age, at Bjarnarhöfn, Snæfellsnes – Bear Harbour – where his father Jón Bjarnason [1943] was a farmer jointly with his brother, Hildibrandur [1936-2017] and father, Bjarni Jónsson [1908-1990] from Asparvik – Aspen-Inlet at Strandir in the Northwest.
A stammer and slow to read
"I had difficulties with reading until finally the age of eight or nine", Ásgeir says in an interview with Icelandic Times. The learning was based on knowing the letters, starting with A and then B and so on. This was Greek to the young boy. To make things worse, he stammered and was bullied. Ásgeir reads differently to most people, as he sees words as pictures. This is possibly a form of dyslexia but Ásgeir has never been diagnosed. He solved that matter himself. "I didn't do well at school and yearned to be able to read", he says. Then one day he was able to connect the dots. Words manifested themselves in pictures and he was able to read, the letters were out of the way. This was a major revelation to him. He started reading the Sagas, beginning with Eyrbyggja, the regional Saga and then the other Icelandic Sagas, one by one. A brave new world appeared to him. "In fact, I became a fast reader almost overnight. That has helped a lot in my studies and job", he says. However, he still makes spelling mistakes as letters tend to mix within words. "I was raised on a farm with no playmates, only adults and the animals. There were no computer games and TV programmes were simple", he says. He spent his time in his grandfather's library and became passionate about the Icelandic Sagas—and still is. At Akureyri's College, he attained 10 in Icelandic on the Sagas. "That is the grade that, to this day after all the studying, I'm most proud of."
Born in Norway 1970
Ásgeir was born at Aas, in Norway in 1970, second of six siblings. His father was studying agronomy at Aas University. In 1971 the family moved to Bjarnarhöfn farm between the towns of Stykkishólmur and Grundarfjörður. It is a well-known farm that had been bought in 1914 by Thor Jensen [1863-1947], a Danish man, who had arrived in Iceland at the age of 13 and led Iceland's fishery revolution at the start of the 20th century. Thor Jensen built sheep sheds at Bjarnarhöfn, even though he was leading Iceland's fisheries revolution. Ásgeir's grandfather and his sons had 700 sheep.
At the age of eleven, Ásgeir moved with his parents to the ancient bishopric at Hólar in Hjaltadal in the north, one of Iceland's most historic places, where Iceland's last Catholic Bishop, Jón Arason [1484-1550] was a central figure. It does not come as a surprise, therefore, that Ásgeir has written about Jón Arason with deep insight. His historical work, "Uppreisn Jóns Arasonar – Jón Arason's Revolt" was published this year. Ásgeir puts the power-struggle between the Danes and Germans into perspective.
Bishop Jón Arason was a Catholic bishop backed by the Germans, however the King of Denmark had signed an Executive Order that Icelanders should turn to Lutheran worship. Bishop Jón Arason was beheaded at Skálholt Bishopric in 1550 and the king's servants raided Iceland's churches and monaster-ies of gold, silver and valuables and transported them to Denmark. That was the beginning of Copenhagen's elite taking over the country, followed by the Trade Monopoly [1602-1787]. Iceland was run as a colony. These were Iceland's Dark Ages.
Economics became his passion
Ásgeir studied at Akureyri's College and graduated at twenty years old in 1990. After pondering about whether to study biology, medical science or become a fisherman, he found his passion in economics and enrolled at Iceland's University. He graduated in 1994. His BS paper, 'Siglt gegn vindi' – Sailed against wind – deals with Iceland's economy from 1400- 1600. The year before his graduation, he began working for the Dagsbrún,– Day Ascending – Labour Union, where Iceland's legendary labour leader Guðmundur Jaki – 'the giant' – Guðmundsson [1927-1997] was supreme. People debated whether the 23-year-old economist was a communist or a liberal, but Gvendur Jaki always referred to him as the "University kid". Ásgeir got to know Iceland's most loved labour leader in his final battle. Gvendur Jaki had revolted against the economists at Iceland's Confederation of Labour and so he wanted a 'foal'. "I was that foal," Ásgeir says with amused expression.
Ásgeir was constantly reading, seeking knowledge. He went to Indiana, USA and finished his Master's Degree from the University of Indiana in 1997 and his doctoral thesis in 2001. Ásgeir has been quoted that his stammering intensified when he was teaching in English. He started speech coaching at Indiana Speech, getting his English stammering out of the way. Dr. Ásgeir Jónsson has had to tackle and defeat his demons to become the man he is and Governor of Iceland's Central Bank.
Chief Economist at 33 years of age
He returned to Iceland and became Chief Economist of Kaupthing Bank, aged 33. At the turn of the century, Iceland's credit was a triple AAA. For some reason, the Financial Supervisory had been moved out of the Central Bank in 1998 during Finnur Ingólfsson's tenure as Minister of Commerce. That took the sting out of the Central Bank. The banks were privatised and what was called 'the modern Viking raids of Europe' began.
"I was a very young Chief Economist. We were new kids on the block, inexperienced. I wasn't in the innermost circle of Kaupthing, although I was the face of Kaupthing as the media sought my comments on Iceland's economy and forecasts", Dr. Ásgeir says. He became well known, quite a celebrity. When the banks collapsed and with them the Icelandic Economy, he became one of the culprits. He started researching what had gone wrong and wrote "Why Iceland, an inside account of the meltdown's fascinating and far-reaching tragedies… in painstaking detail". "Why Iceland" was written in English and translated into Japanese, German and Arabic. It is the most referred to book on Iceland's banking collapse.
Dr. Ásgeir was involved in Kaupthing's resurrection with new name, Arion Bank. At the age of forty, he wanted a change so he left banking. He became professor at Iceland's University. It came as a surprise to many when, eight year later, Dr. Ásgeir was appointed Governor of the Central Bank—and some were quite critical. Dr. Ásgeir finds that understandable. "I believe that none of us who were in the whirlpool of the Collapse are the same. In retrospect, I would have done things differently. However, my involvement in the Collapse in itself helps me. I know the banks inside out and the pitfalls to debate the banks, as well as other special interest groups. Unlike my predecessors, I have inside knowledge of the banks. That gives me confidence in the never-ending struggle between special interest groups", he says.
Despite the Banking Collapse of 2008, Dr. Ásgeir believes that those years had their positives. Iceland managed to establish massive international firms that are still operating. Governments have done well in the build-up after the Collapse and the Emergency Laws were the foundation to refinance the economy. Icesave united the nation, as it revolted against UK, Dutch and EU bullying. "Companies, politics and the public learnt their lesson. We are more careful. This can be seen in how companies are run, with fewer debts and more professionalism", he says. "The banks took over Iceland, didn't they?" "Yes, they did", he answers.
Tragic loss of a sister in 2011
The years after the Collapse were difficult for Dr. Ásgeir and his family. His sister Katrín died of cancer in 2011. He discussed the loss with Fréttablaðið before he took office in 2019. "When people get sick with cancer, the younger they are, the tougher the sickness. Katrín was diagnosed with the disease, went into therapy, and seemed to be cured. However, the disease resurfaced, and she died in only six months", he says. "It was horrifying to see how the cancer took everything from this beautiful young woman, who had been so healthy. Her sight, movements and then life itself."
It is obvious that it is tough to recall. "This was immense and without warning. It shocked everyone in the family. Katrín had always been healthy, and cared for herself better than most," says Dr. Ásgeir. "Neither my parents nor brothers and sisters have been the same since and we've stuck together more. After such loss, one understands better what really matters in life", said Dr. Ásgeir in the interview with Fréttablaðið. His father, Jón Bjarnason, served in the government of Samfylking and Vinstri græn—the Left Alliance and Left Greens — from 2009-2011, when his daughter died.
Appointment not politically biased
How is Dr. Ásgeir Jónsson different from his predecessors? "People don't know me for my political standpoints nor was the appointment based on politics. I'm independent of special interests. My commitment is to the Icelandic people and their well-being", he says. No special interest group was involved in his appointment. Freedom of Speech is the Governor's weapon and he's fearless in taking on special interests, such as the pension funds or labour unions, companies and their Confederation, quota-owners and politicians. He has, for example, criticised the political parties for not building Sundabraut – the main road out of Reykjavík to the west and north, the municipality of Reykjavík, for inexplicable lack of building land and the giant fishing company, Samherji in Akureyri, in their quarrels with the Central Bank, criticizing, naming and going after individual public servants.
"I'm independent and I realize that I am dealing with powerful special interest groups, who may or may not be happy. I am my own master, and my allegiance is with the people of Iceland and their interest. I realize that this may lead to me not serving a second term. If so, then so be it", says Dr. Ásgeir.
Welfare policy and low interest rates
The Central Bank's policy is to ensure the people's welfare. Stability is key, he says. "The monetary policy is crucial for low-income people, who stand to lose most if inflation gets out of hand or during recession. This is my focal point; it matters to me. The monetary policy is welfare policy. My goal is low inflation and low interest rates. These are fundamentals for a higher standard of living in Iceland", he says.
Dr. Ásgeir, criticizing Samherji for attacking individuals at The Central Bank, was much talked about, but can it continue, that 12-15 people – or what the actual number may be – are in charge of Iceland's fishing quotas with a yearly turnover of ISK 300 billion – over 2.3 Billion US Dollars? "This is a political question, which in itself is not for me to decide or debate," he says.
Dr. Ásgeir points out that The Central Bank, for the first time in Iceland's economic history, has powerful tools and independence at its deposal to ensure stability. It's a different era. A solid króna is key to Iceland's solid economy. With the merger of The Central Bank and The Financial Supervisory in 2020, the Bank got wide-ranging authority. Never before has an institution had such wide-ranging powers over the commercial banks. The Currency Reserve is at a historical high of ISK 900 Billion – 7 Billion US Dollars – and that's huge for a nation of 330 thousand. "Iceland had soft landing at the end of Covid. The Bank sold ISK 200 Billion of its Currency Reserve, ensuring stability. Icelanders are, like never before, at a crossroads to run their economy and deal with inflation and depression. The Króna did well through Covid's rough seas. Never in Iceland's economic history, has an institution had such responsibility as does The Central Bank at present", says the Governor.
The Soft Landing
Dr. Ásgeir emphasizes that he must hold his cool and not overestimate himself but stay humble. The Icelanders are fatalists, nature gives and nature takes and all will be well. These elements are engraved in the nation's psyche. The nation has shown serenity in face of adversity, for example during the Cod Wars with Britain, The Banking Collapse and now the Covid pandemic. The Central Bank worked closely with the government during Covid, and the nation had weathered the storm. Now, it's important to ensure balance in government spending. We see the Mediterranean nations struggling, and indeed Europe and America, where money is being printed feverishly, meaning inflation and a lower standard of living in the Western World. Uncertain times are ahead but Iceland is in better shape to deal with the future than most nations.
Uppreisn Jóns Arasonar – Jóns Arason's Revolt – by Dr. Ásgeir Jónsson is a must-read about one of Iceland's most dramatic and consequential event. With the execution of Hólar's Catholic Bishop, Jón Arason, governmental power was moved to Copenhagen. The king took over land ownership of the Church, fish and brimstone. He confiscated all of the gold, silver and valuables, which were transported abroad. Copenhagen's merchants were handed Iceland to exploit and the infamous Monopolistic Trade [1602-1787] was enforced. Iceland was closed to foreign relations. Iceland practically became a Danish colony. Iceland's dark ages followed with poverty and isolation. Jón Arason [1484-1550] was the son of a widow, born at tiny cottage Grýta in Eyjafjördur in the North, educated at Munkaþverá Cloister close by. He became a Catholic bishop at the age of 36. Jón Arason postponed the Lutheran Reformation for almost a decade. He had reached agreement with King Christian III [1534-1559] that Hólar bishopric would continue to be Catholic, and his son Sigurdur would succeed him. However, there was an intense power struggle involving Iceland. Jón Arason was born towards the end of the "English" 15th century when the English and the Germans would grapple to buy fish from the locals. Dr. Ásgeir writes about the commercial war between the Danes and Germans that started in 1547. Jón Arason started his Armed Revolt supported by the Germans. He proclaimed the whole of Iceland as Catholic. Jón Arason lost a key battle at Sauðafell at the Valleys, Western Iceland and was taken prisoner along with his two sons. They were beheaded at the Skálholt bishopric in the South. The following year, an armed militia moved to Southern Iceland and killed all the Danes they got their hands on—almost 20 men, as well as the king's Ombudsman, an Icelander. Dr. Ásgeir puts this into context with the European politics of the time.
Hallur Hallsson
Hallur Hallsson is a leading journalist, writer, and historian in Iceland. Former TV anchor who worked at both leading TV networks; State TV and TV 2. He worked at Iceland's leading newspaper Morgunblaðið and was one of the founders of Dagblaðið.


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Knocking Over the System – Week of April 20-26 2016
April 19, 2016 Astrology up to dateGimel
With both Mars and Pluto turning retrograde this week, it is not a good time to press forward. While reviewing and/or revising old projects, the opportunity is for the refinement of goals. Saturn and Jupiter remain retro motion as well, so we might recognize that the overwhelming move is for removing the outmoded and broken-down system and those who profit from it. It goes beyond politics, although politics certainly has a place in this over-all view of the social and personal issues we face today.
While we like to think of the present as a unique time, historically, and a time of unprecedented dissatisfaction with the "system," one has only to look closely at history to find that throughout recorded history, the "system" was an object of contempt. If so, that must have more of a reflection on human nature than primarily the external affairs of the nation. Samuel Butler, in 1903, wrote in The Way of all Flesh (p 281) "The trouble is that in the end we shall be driven to admit the unity of the universe so completely as to be compelled to deny that there is either an external or an internal, but must see everything both as external and internal, at one and the same time, subject and object-external and internal- being unified as much as everything else. This will knock our whole system over, but then every system has got to be knocked over by something." However, we should make sure we have something better to put in its place.
Summary of major aspects of the week:
Wednesday April 20th – With the Sun in Taurus today, and the Moon in Libra, we are attuned more to pleasure and comfort, security and profit, maintaining the status quo, as good feelings toward the community are favored. Venus in Aries is the dipositor of both the Sun (in Taurus) and the Moon (in Libra), as it inexorably moves toward a conjunction with Uranus. Today, the Moon in Libra opposes Venus, keeping a balanced outlook, while claiming satisfaction. However, the veneer belies a situation that will be exposed in the next 48 hours.
Thursday April 21st – With four planets and Ceres in fire signs, direct and ambitious energy predominates. While Mars and Saturn are both in a retrograde phase, the goal to repair (Jupiter in Virgo) or dissolve (Neptune in Pisces) existing agendas is pushing us forward. Existing patterns of action are likewise circumspect. Mars turned inward may put obstacles in the path, may also indicate a time needed for physical or mental recuperation. The Moon's opposition to Venus and Uranus could indicate advance warning messages, even as earthquakes have already taken a toll. More upsets are likely.
Friday April 22nd – The Full Moon in the early morning hours is another trigger for real or symbolic earthquakes. The Moon in Scorpio now, is ripe for in-depth revolution. Fundamental change seems to be the call of the day. Revelations of hidden resources might be exposed as well. Yet, the goal should be for positive change, even as painful circumstances call for emergency actions. Venus is in a close conjunction with Uranus today, in Aries, indicating the shock waves throughout the world. The voice of a healing personality wins support Mercury in Taurus is sextile aspect (60 deg) to Chiron in Pisces. Other indications include the Jupiter–Neptune opposition, as well as Venus in semi–sextile aspect to both Mercury and Chiron.
Oppositions and dis-array
Saturday April 23rd –The calming voice of wisdom, the leadership that will be a guide and a warrior emerges. Global set-backs can slow the pace of change, as Neptune is square (90 deg aspect) Mars and Saturn in Sagittarius. Jupiter in Virgo opposes Neptune with a 2 deg orb, so international aid is elicited. Finding, at last, the pieces of an airlines that mysteriously disappeared two years ago, can be grim news for the families of the victims. The extent of the damage from earthquakes this past week, becomes known, as survivors are struggling to cope.
Sunday April 24th – The Moon enters Sagittarius, as more blame and responsibility is targeted (the archer's arrow). Earth and fire are the operating energies, redirecting wealth and human resources to aid and assist where most needed. Human tragedies draw out compassion, helping to realign the distribution of resources. (Jupiter opposition to Neptune) Humanitarian actions are called upon by the charities involved world-wide.
Monday April 25th – While spontaneous actions of generosity exist (Moon transits Mars), the tightening of the hand (Saturn in Sag conj the Moon) limits the power of out-reach. Hardships are yet to be overcome, as the difficulty is reaching those affected in time of greatest need. The Moon in a square (harsh 90 deg) aspect to Jupiter in Taurus, and to Neptune in Pisces, forms a T–square configuration, and highlights the very un-stable conditions of the day.
Tuesday April 26th – The Moon travels on to form trine aspects to Uranus and Venus today. Perhaps a closer look at the situation is provided with on the scene reports. While this is a constant in this day and age, the electronic media (Uranus in Aries) is at a high-point, with the Moon in Sagittarius trine (120 deg aspect) to Uranus and quincunx (150 deg aspect) to Mercury in Taurus.
Have a great week, and thanks for reading my notes.
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About Gimel
Astrology has brought me a core understanding of how our universe is synchronized with life and our role as individuals. It has brought me greater understanding of human nature. I have studied the subject since 1968 and continue to be in awe this wonderful expression of creation. My personal website is shoshanawerbner.com and I also administrate stopaddictionforlife.com Please visit my other websites as well. Thank you for visiting the site.	View all posts by Gimel →
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McDermott Partners Recognized As Digital Health Power Players
By McDermott Will & Emery on Aug 13, 2021
Washington (August 11, 2021) – McDermott Will & Emery partners Jennifer Geetter and Vernessa Pollard have been recognized within an Insider profile on the "9 behind-the-scenes players who can make or break your digital-health startup." The pair discussed advising young companies on the regulatory hurdles they have to clear before tackling the healthcare market.
As part of the Firm's industry-leading health practice, Jennifer advises digital health companies on the development, delivery and implementation of innovative healthcare solutions. Vernessa leads medical device and technology companies through US Food and Drug Administration (FDA) regulations to bring products to market.
Vernessa explored with Insider how more tech companies are spreading into healthcare. These companies need assistance discussing the FDA's newest regulations, including machine learning oversights or health-data privacy rules. If businesses are not knowledgeable about their regulatory requirements, it can make or break their investments.
"We have a number of what we'd consider to be nontraditionally FDA regulated entities, such as the large tech companies and even hospitals and healthcare providers, that are entering this space because they're developing new tools or technology that may trigger FDA requirements," Vernessa noted.
Jennifer explained that it's not always clear if decade old FDA laws apply, so she advises her clients to prioritize building trust with patients through an emphasis of privacy and cybersecurity protection.
"There's something about the intimacy of the standard doctor-patient relationship when you're sitting across the room from your doctor that breeds trust," Jennifer said. "When you're in a digital healthcare system with distance, you don't necessarily have that."
McDermott Will & Emery is the nation's leading health law firm. The Health Industry Advisory group is the only health practice to receive top national rankings from U.S. News – Best Lawyers "Best Law Firms," Chambers USA, The Legal 500 US and Law360. The practice was also recognized by Chambers as "Health Team of the Year" in 2010, 2013, 2017 and 2019. McDermott has also held the top spot in PitchBook's League Tables as the most active firm for healthcare private equity since 2017.
FDA Issues Artificial Intelligence/Machine Learning Action Plan
By Vernessa T. Pollard and Anisa Mohanty on Jan 20, 2021
On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD:
Further develop the proposed regulatory framework, including through draft guidance on a predetermined change control plan for "learning" ML algorithms
FDA intends to publish the draft guidance on the predetermined change control plan in 2021 in order to clarify expectations for SaMD Pre-Specifications (SPS), which explain what "aspects the manufacturer changes through learning," and Algorithm Change Protocol (ACP), which explains how the "algorithm will learn and change while remaining safe and effective." The draft guidance will focus on what should be included in an SPS and ACP in order to ensure safety and effectiveness of the AI/ML SaMD algorithms. Other areas of focus include identification of modifications appropriate under the framework and the submission and review process.
Support development of good machine learning practices (GMLP) to evaluate and improve ML algorithms
GMLPs are critical in guiding product development and oversight of AI/ML products. FDA has developed relationships with several communities, including the Institute of Electrical and Electronics Engineers P2801 Artificial Intelligence Medical Device Working Group, the International Organization for Standardization/ Joint Technical Committee 1/ SubCommittee 42 (ISO/ IEC JTC 1/SC 42) – Artificial Intelligence, and the Association for the Advancement of Medical Instrumentation/British Standards Institution Initiative on AI in medical technology. FDA is focused on working with these communities to come to a consensus on GMLP requirements.
Foster a patient-centered approach, including transparency
FDA would like to increase patient education to ensure that users have important information about the benefits, risks and limitations of AI/ML products. To that end, FDA held a Patient Engagement Advisory meeting in October 2020, and the agency will use input gathered during the meeting to help identify types of information that it will recommend manufacturers include in AI/ML labeling to foster education and promote transparency.
Develop methods to evaluate and improve ML algorithms
To address potential racial, ethical or socio-economic bias that may be inadvertently introduced into AI/ML systems that are trained using data from historical datasets, FDA intends to collaborate with researchers to improve methodologies for the identification and elimination of bias, and to improve the algorithms' robustness to adapt to varying clinical inputs and conditions.
Advance real world performance monitoring pilots
FDA states that gathering real world performance data on the use of the SaMD is an important risk-mitigation tool, as it may allow manufacturers to understand how their products are being used, how they can be improved, and what safety or usability concerns manufacturers need to address. To provide clarity and direction related to real world performance data, FDA supports the piloting of real world performance monitoring. FDA will develop a framework for gathering, validating and evaluating relevant real world performance parameters [...]
The Toughest Problem Set: Navigating Regulatory and Operational Challenges on University Campuses
By Jennifer S. Geetter and Michael W. Ryan on Aug 27, 2020
Posted In Data Privacy, Mobile Apps, Workplace Privacy
When the academic year ended in the spring of 2020, many US university students assumed that a return to campus would be straightforward this fall. However, it is now clear—at least in the near term—that a return to the old "normal" will not be possible. Some universities have concluded that their best course of action is to offer only distanced learning for the time being. Other universities, however, are welcoming students back onto campus, and into residence and dining halls, classrooms, labs and libraries. Each of those universities is developing its own approach to retain the benefits of on-campus student life while reducing risk to the greatest extent possible; nevertheless, some have had to adjust their plans to pivot to remote learning when faced with clusters of positive cases on campus. One thing is clear: The fall semester will be a real-time, national learning laboratory.
Because widespread, rapid testing remains unavailable in many locations, universities have had to find innovative ways to implement testing, tracing and isolation protocols to reduce the risk of transmission among students, faculty and staff. There is no one perfect protocol—all universities are in unchartered waters. But there are a few key components university administrators may want to consider and address:
Apps: Symptom checkers, contact tracing and other apps can be useful in identifying and focusing attention on the onset of symptoms, fostering accountability and identifying high-risk exposure. In considering whether to incorporate apps and related technologies into their back to campus plans, universities must anticipate and address considerations related to privacy, security and reporting of results, and will need to consider how such apps are hosted (for example, through Apple's App Store) and whether any third parties will have access to the personal data collected.
Contact Tracing: In addition to the issues noted above, contact tracing efforts also present other challenges, including managing reliability, over/under inclusiveness and liability (for both false positives and false negatives). In addition, the effectiveness of contact tracing is closely tied to its speed and comprehensiveness; to implement a successful contact tracing program, universities will need to balance effectiveness with privacy and autonomy.
CLIA: The Clinical Laboratory Improvement Act (CLIA) will require that many of the tests be performed in CLIA-certified (and state-licensed, where required) space. Universities will need to consider how best to handle building out additional compliant space, creating additional "point of care" testing or specimen collection sites if needed to test students, faculty and staff where they are and validating the test(s) being offered. Tests that are not yet validated likely cannot be used to return patient-specific results that inform student and staff care or be used to prompt "official" testing.
FDA/Emergency Use Authorizations (EUA): In general, the Food and Drug Administration (FDA) expects developers of molecular, antigen and (in the case of test kit manufacturers) antibody tests to obtain an EUA. However, under FDA enforcement policies during the pandemic, many of these same tests—if validated and offered with appropriate agency-mandated disclaimers—can be offered before [...]
Available Now – 2019 Digital Health Year in Review
By McDermott Will & Emery on Jan 28, 2020
Posted In Consumer Protection, Data Privacy, General Interest
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product research, development and commercialization, for long-standing and new stakeholders alike. Lawmakers and regulators made meaningful progress towards modernizing the existing legal framework to both protect patients and consumers and encourage continued innovation, but these efforts still lag behind the pace of digital health innovation. As a result, some obstacles, misalignment and ambiguity remain, and 2020 will likely be another year of significant legal and regulatory change.
Click here to read our review of key developments that shaped digital health in 2019 and set the groundwork for trends in 2020.
US Office of Management and Budget Calls for Federal Agencies to Reduce Barriers to Artificial Intelligence
By Bernadette M. Broccolo on Jan 17, 2020
Posted In Big Data, Consumer Protection, Data Privacy, Telehealth
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal "implementing agencies" regarding the development of regulatory and non-regulatory approaches to reducing barriers to the development and adoption of artificial intelligence (AI) technologies. Implementing agencies are agencies that conduct foundational research, develop and deploy AI technologies, provide educational grants, and regulate and provide guidance for applications of AI technologies, as determined by the co-chairs of the National Science and Technology Council (NSTC) Select Committee. To our knowledge, the NTSC has not yet determined which agencies are "implementing agencies" for purposes of the Memorandum.
Submission of Agency Plan to OMB
The "implementing agencies" have 180 days to submit to OMB their plans for addressing the Memorandum.
An agency's plan must: (1) identify any statutory authorities specifically governing the agency's regulation of AI applications as well as collections of AI-related information from regulated entities; and (2) report on the outcomes of stakeholder engagements that identify existing regulatory barriers to AI applications and high-priority AI applications that are within the agency's regulatory authorities. OMB also requests but does not require agencies to list and describe any planned or considered regulatory actions on AI.
Principles for the Stewardship of AI Applications
The Memorandum outlines the following as principles and considerations that agencies should address in determining regulatory or non-regulatory approaches to AI:
Public trust in AI. Regulatory and non-regulatory approaches to AI need to be reliable, robust and trustworthy.
Public participation. The public should have the opportunity to take part in the rule-making process.
Scientific integrity and information quality. The government should use scientific and technical information and processes when developing a stance on AI.
Risk assessment and management.A risk assessment should be conducted before determining regulatory and non-regulatory approaches.
Benefits and costs. Agencies need to consider the societal costs and benefits related to developing and using AI applications.
Flexibility. Agency approaches to AI should be flexible and performance-based.
Fairness and nondiscrimination. Fairness and nondiscrimination in outcomes needs to be considered in both regulatory and non-regulatory approaches.
Disclosure and transparency. Agencies should be transparent. Transparency can serve to improve public trust in AI.
Safety and security. Agencies should guarantee confidentiality, integrity and availability of data use by AI by ensuring that the proper controls are in place.
Interagency coordination. Agencies need to work together to ensure consistency and predictability of AI-related policies.
Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents
By Anisa Mohanty, Michael W. Ryan and Vernessa T. Pollard on Oct 4, 2019
Posted In General Interest, Mobile Apps
The 21st Century Cures Act, enacted in December 2016, amended the definition of "medical device" in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical device guidance documents. FDA also stated that it would continue to assess how to update and revise these guidance documents as its thinking evolved.
Late last week, FDA issued five final guidance documents and re-issued a draft guidance document to better reflect FDA's current thinking on software as a medical device (SaMD) and other digital health products:
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Guidance for Industry and Food and Drug Administration Staff
General Wellness: Policy for Low Risk Devices – Guidance for Industry and Food and Drug Administration Staff
Policy for Device Software Functions and Mobile Medical Applications – Guidance for Industry and Food and Drug Administration Staff
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices – Guidance for Industry and Food and Drug Administration Staff
Off-The-Shelf Software Use in Medical Devices – Guidance for Industry and Food and Drug Administration Staff
Clinical Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff
Most of the guidance documents reflect modest changes to prior draft guidance documents that describe categories of low-risk health and wellness devices that FDA does not intend to regulate. FDA's new draft Clinical Decision Support (CDS) Software guidance, however, provides a new and more detailed analysis of risk factors that FDA will apply to determine whether a CDS tool is a medical device. FDA updated its previously issued draft CDS guidance without finalizing it. Although the new guidance does not explain why FDA is reissuing the CDS guidance in draft, the new draft guidance seems to reflect the agency's attempt to better align its definition of non-device software with the often misunderstood and misinterpreted statutory definition of CDS in section 520(o)(1)(E) of the Cures Act. The chart below summarizes the key provisions and changes to these guidance documents.
Digital health products can present a particular challenge for developers and regulators in assessing the appropriate regulatory pathways for a new product. The updated guidance documents reflect the need for a more flexible, risk-based approach to regulation that accommodates a rapidly evolving technological landscape. These documents also reflect what appears to be the new normal for digital health regulation—the need for iterative thinking and ongoing revisions to interpretive guidance documents to keep pace with a constantly changing marketplace.
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To Market, To Market: FDA's Digital Health Precertification Program
By Vernessa T. Pollard on Sep 18, 2019
Posted In Cybersecurity, General Interest
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software applications and other transformative technologies, such as artificial intelligence and 3D printing, are reshaping how medical devices are developed, and FDA is seeking to align its mission and regulatory obligations with those changes.
FDA's digital health software precertification program is a prime example of this approach. Once fully implemented, this voluntary program should expedite the path to market for software as a medical device (SaMD), and promote greater transparency between FDA and regulated entities.
Under the program, FDA will conduct a holistic review of the company producing the SaMD, taking into account aspects such as management culture, quality systems and cybersecurity protocols, to ascertain whether the company has developed sufficient infrastructure to ensure that its products will comply with FDA requirements and function safely as intended. Companies that fulfill the requirements of the excellence appraisal and related reviews will receive precertification that may provide for faster premarket reviews and more flexible approaches to data submissions at the outset.
Reviewing Key Principles from FDA's Artificial Intelligence White Paper
By Anisa Mohanty and Vernessa T. Pollard on Aug 28, 2019
Posted In General Interest
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device," announcing steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced AI algorithms. AI, and specifically ML, are "techniques used to design and train software algorithms to learn from and act on data." FDA's proposed approach would allow modifications to algorithms to be made from real-world learning and adaptation that accommodates the iterative nature of AI products while ensuring FDA's standards for safety and effectiveness are maintained.
Under the existing framework, a premarket submission (i.e., a 510(k)) would be required if the AI/ML software modification significantly affects device performance or the device's safety and effectiveness; the modification is to the device's intended use; or the modification introduces a major change to the software as a medical device (SaMD) algorithm. In the case of a PMA-approved SaMD, a PMA supplement would be required for changes that affect safety or effectiveness. FDA noted that adaptive AI/ML technologies require a new total product lifecycle (TPLC) regulatory approach and focuses on three types of modifications to AI/ML-based SaMD:
FDA's Breakthrough Device Program: Opportunities and Challenges for Device Developers
By Anisa Mohanty and Vernessa T. Pollard on Jul 24, 2019
As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program.
There are two criteria for inclusion in the Breakthrough Device Program:
The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and
The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients.
Three Tips for Tackling Risk in Digital Health
By Dale C. Van Demark and Lisa Mazur on Jul 12, 2019
Digital health companies face a complicated regulatory landscape. While the opportunities for innovation and dynamic partnerships are abundant, so are the potential compliance pitfalls. In 2018 and in 2019, several digital health companies faced intense scrutiny—not only from regulatory agencies, but in some cases from their own investors. While the regulatory framework for digital technology in health care and life sciences will continue to evolve, digital health enterprises can take key steps now to mitigate risk, ensure compliance and position themselves for success.
Be accurate about quality.
Ensuring that you have a high-quality product or service is only the first step; you should also be exactingly accurate in the way that you speak about your product's quality or efficacy. Even if a product or service does not require US Food and Drug Administration clearance for making claims, you still may face substantial regulatory risk and liability if the product does not perform at the level described. As demonstrated in several recent public cases, an inaccurate statement of quality or efficacy can draw state and federal regulatory scrutiny, and carries consequences for selling your product in the marketplace and securing reimbursement.
Tech companies and non-traditional health industry players should take careful stock of the health sector's unique requirements and liabilities in this area, as the risk is much higher in this arena than in other industries.