Thursday, April 30, 2015

Unity Farm Journal - Fifth Week of April 2015

I’ve been in China this week helping the government of Shenzhen with medical education and innovation.   Kathy has been in charge of the farm.

Before any trip, I do my best to prepare the farm for my departure - maintaining every electrical, plumbing/water, and building issue I can think of.   All of the young plants/trees are irrigated, animals fed/watered, and every supply fully stocked.  The trails are clear, the fallen limbs bucked up, and the mushrooms harvested.   A few of our Shitake varieties fruit in the Spring and we’ve already been gathering our first mushroom harvest of 2015.

Our hoop house beds have been bursting with heads of red romaine, winter density lettuce, and spinach.   Kathy's been making salads for herself, the poultry, and the alpaca/llama.  Even the dogs enjoy a small salad, munching the crisp green leaves while lying under the hay feeder.

Kathy's been tending the newly planted squash and pumpkins, as well as readying the heat-loving peppers and eggplant for planting on my return, when the chance of frost will be less.  

During my absence she’s been preparing more bee hives which she’ll use to create “splits” - dividing mature colonies before they swarm in June.   She’s also put up a swarm trap - a container likely to attract bees should one of the hives still decide to swarm.     This year we’ll end up with 18 hives - a combination of Russians, Italians, and Carniolan bees.  All are gentle, busily gathering pollen and raising brood.

Last week, a commenter asked a question about the reason we paint each bee hive a different color.  Here’s Kathy’s answer:

"Bees see different colors than humans, and are notably able to see in the ultraviolet range. The color of the hives boxes serve three purposes. One is simple fun aesthetics. More importantly, the dark colors used on the brood boxes in the center of the stack are to warm the hive in the winter by absorbing the heat of the sun more efficiently. We follow the successful experiences of Overland Honey of Portland Maine in the use of darker colors in northern beekeeping practice. The third use of color on the hives is to reduce drift from hive to hive by the foragers. By creating unique color patterns especially at the landing board, we hope to increase bees accuracy at returning to the correct home hive."

I return to Boston tomorrow and will spend the weekend catching up on all I missed.  Not only does Kathy miss me, but the Great Pyrenees are waiting for one of their mile long runs around the farm in search of turkey, deer, and chattering red squirrels (chickaree).

Wednesday, April 29, 2015

Dispatch from China

The first part of this week I have been in China - Shenzhen, Shanghai, and Suzhou as part of a Harvard Medical School program to help the Chinese create a learning healthcare system while they build 1000 new hospitals and train 300,000 new primary care givers.

Ajay Singh, Tom Tsai, Li Zhou and I served as faculty for the two day course, reviewing best practices in safety, quality, informatics and leadership.

My role was to describe the benefits of informatics, the characteristics of a highly usable EHR, and to predict the future of big data/analytics, mobile, and cloud computing in a way that provided the Chinese with inspiration as they plan their investments.

We had dinner with the vice Mayor of Shenzhen and several public health leaders.  Then the Mayor of Shenzhen, Qin Xu, officially launched the Harvard-Shenzhen collaborative in front of 200 government, academic, and industry experts.

Every time I visit China, I learn a bit more about their healthcare system.

Like the US, China is a mixture of rural and urban healthcare settings with different resources, facilities, and people.  

China wants to encourage innovations such as implementing decision support, creating standardized care plans, and accelerating the use of telemedicine.

We discussed that technology is not sufficient - it must be complemented with enabling policy and an urgency to improve the healthcare system.

On Wednesday afternoon (local time) I toured hospitals and studied their EHRs.   As in the US, there are a large number of EHR vendors in China.  Unlike the US, there is no Epic, Cerner or Meditech - hospitals tend to adopt solutions created by local vendors.

My hope is that Harvard can share healthcare IT experiences from throughout the world, both good and bad, to help make a difference in the lives of 1.3 billion Chinese people.   China will soon be the largest economy in the world, with the largest population, and unprecedented demand for healthcare services.      Although I work to improve the healthcare of the US every day, sharing lessons learned with other countries and helping them achieve their goals  with greater speed and less cost, is very gratifying.

I'm back in Boston on Friday and then in Eastern Europe for a few days in early May.   My travel for the rest of the year is minimal, so I can focus on planning the operating and capital budgets of the BIDMC IT empire over the Summer.  

Thursday, April 23, 2015

Unity Farm Journal - Fourth Week of April 2015

This week a coyote visited the barnyard during the day.   Daytime activity is not unusual for females which have an active den of hungry pups.   We have fox, coyote, and fisher cat dens at Unity Farm, so there is a high predator load.   What happened?  The guinea fowl alarmed.  You would think that this would cause the 65 guinea fowl to flee - seeking safety in the coop or the top of tree.   Instead, all 65 guinea fowl assembled from  throughout the 15 acres of the farm and charged the coyote, chasing it off the property.   The coyote turned and threatened the guineas a few times but there is nothing like 65 screaming guineas to intimidate any predator.   Later in the day I walked the Great Pyrenees along the trails where the coyote was running and they franticly followed the scent.   As livestock guardian dogs, they know the coyote is their natural enemy.   No lives were lost and the coyote has not returned.

It’s spring and time to restart our usual monthly healthcare routine for all the creatures of the farm.    We inspected the eyes, ears, skin, and feet of every animal, trimming toenails, removing ticks, and applying ointments to winter-cracked skin.    The good news is that everyone is happy and healthy.

We’ve been hard at work building new hives, new hive stands, and portable bee benches.    Kathy has agreed to install Unity Farm hives in Medway, Holliston, and Wellesley.  Soon we’ll have Unity Farm bees gathering pollen over a 15 mile radius.

Kathy and I bottled 10 cases of Unity Farm hard cider last weekend.   In my medical school years when I ran Woodcliff Winery in the 1980’s (near the Marin County Civic Center), winemakers from Mondavi, Phelps, and Bonny Doon taught me everything I know about fermentation.  The cider I make today uses the same methods as french chardonnays.  I import the yeast and malo-lactic bacteria cultures from France.   My wife was has declared that Unity Farm ciders taste more like Dom Perignon than Angry Orchard.   Here’s a photo of my hand bottling each 22 ounce container from the carbonation kegs

We ordered our 2015 mushroom spawn this week.   We’ll inoculate 2 different subtypes of Shitake, 1 type of Nameko,  1 type of Gandoderma Lucidum (Reishi) and 1 type of Agarcus Augustus (Almond Agaricus) this year.    The Gandoderma is a healing mushroom from China and next week I will discuss a clinical trial of the mushroom for cancer care with colleagues in Shenzhen, China where I will be planning a healthcare IT innovation center with the mayor.

We’ve planted our 2015 zucchini and kabocha squash (Japanese pumpkin) in a 25x25 foot bed of alpaca manure, 2 feet deep.   We’re looking forward to a bumper crop this year, but we’re a bit wary of the frost warning tonight, so we’ve covered every plant with a cloche.   The rhubarb is already sprouting

On Sunday morning I begin my 23.5 hour commute to Shenzhen, so Kathy will keep the farm running in my absence.  It’s challenging to be gone during planting season, but the opportunity to make a difference in the healthcare of 1.3 billion people is compelling.

Wednesday, April 22, 2015

The April 2015 HIT Standards Committee Meeting

The April 2015 HITSC meeting focused on the Certification Rule NPRM and a comprehensive review of the Federal Interoperability Roadmap.

I suggested that a guiding principle for the committee’s work is to emphasize the enablers in the proposals while reducing those aspects that create substantial burden/slow innovation.   As a federal advisory committee our job is to temper regulatory ambition with operational reality.  

First, Dawn Heisey-Grove provided an overview of Medicaid eligible professionals’ progress towards Meaningful Use.

Next, Steve Posnack and Michael Lipinski provided a detailed review of the Certification Rule NPRM.      We congratulated Steve and Michael on a great analysis and look forward to public comments.   Th advice from the committee included

*The scope needs to reviewed through the lens of prioritization.    Not every stakeholder desire is of equal impact
*Each candidate standard needs to be reviewed for maturity/adoption
*It is better to do a few things well at depth than to pursue breadth superficially
*The burden of the entire regulation, not its component parts, needs to be considered
*Some requirements are best left at a functional level (as was done for APIs) rather at a prescriptive standards level, especially where standards are immature

Steve announced the formation of a Standards Advisory Task Force to review the NPRM comments which we will discuss at the May meeting.

When then turned our attention to the interoperability roadmap.

Jamie Ferguson presented the findings of the Semantic Standards Workgroup.   Key points included
* Data standards (e.g., for performance and quality measures, public health) should reflect the
semantics implemented in EHR systems and semantics in EHR should be the same across
* Need attention to challenges of data aggregation , for example for resolving duplicates,
when data is assembled from multiple sources
* It is critically important for data provenance to be workable and practical for semantic

Dixie Baker and Lisa Gallagher presented  the findings of the Transport and Security Standards workgroup.  They recommended that ONC partner with the NIST, OCR, and other federal agencies, and industry to enable a uniform approach to enforcing cybersecurity in healthcare.  ONC together with OCR, other federal partners, and industry stakeholders  should continue to support the National Strategy for Trusted Identities in Cyberspace (NSTIC) program and to draw from existing pilots, where applicable.  ONC should support NIST’s effort to update SP 800-63 and to help assure its applicability to and utility for healthcare use cases.  ONC should also provide guidance that defines computable, discrete data fields needed for negotiating patient consent and access to health information.

Andrew Wiesenthal and Rich Elmore presented the findings of the Content Standards Workgroup.
They recommended improved consistency in the implementation of Consolidated CDA through further guidance or constraints, extension of standards to promote exchange across the care continuum, including new sources of patient generated health data, device/sensor, environmental and other big data.  They also noted that APIs by themselves will not open up clinical systems for learning, an ecosystem, culture, and policy are important enablers.

Liz Johnson and Cris Ross presented the findings of the Implementation, Certification, and Testing Workgroup.  Key points included:
*Testing tools need to be available with adequate lead time for pre-certification testing and should be
focused in areas that provide value for end users. Where possible, providers should be involved in
development of test tools.
*CCDA Simplification has occurred between Release 1 and Release 2.
* Practical, effective, and industry-run tools are needed for post-certification testing in support of
interoperability, and evolution of vocabularies, technologies and processes between regulatory

Finally David McCallie and Arien Malec presented the findings of the Architecture, Services, and APIs workgroup.   They presented a framework for evaluating technology policy surrounding health information technology.    I believe their work is foundational to the future thinking about interoperability and could only be proposed now because of the current technologies available to us such as FHIR-based APIs.

All reports were approved by consensus for transmission to ONC.   10 members of the Standards Committee will leave the group when their terms expire in June.   I will leave the Standards Committee when my term expires in January 2016.    It will be fascinating to watch the transition.  Will the consensus change when the membership changes?    In June we will celebrate the amazing contributions of those who have served for their 6 year term limit.

Thursday, April 16, 2015

Unity Farm Journal - Third Week of April 2015

The daytime temperatures are in the 60’s and the evening temperatures are in the 40’s.   The heated buckets in the barn can finally be retired.   The heated bases for the poultry waterers and stock pond can be unplugged.   The chance of frost will continue until late May, but the daily sub-freezing temperatures have passed.   The row covers are off the hoop house raised beds.

With temps in the 60’s Kathy can finally work the bees,   she’s cleaning, feeding, and organizing the hives.   She’s preparing for the spring swarming behavior  and has readied our “splits” - hives to take on the colonies that are going to swarm.    We’ll expand our hives from 12 to 16 and begin a queen breeding program over the next few months.  Kathy is mentoring other beekeepers and will be housing a few hives in Wellesley and Holliston as part of achieving diversity and robustness in our bee colonies.    She's busy painting hives and I'm building new hive stands.

The cider is now carbonated and we’re bottling this weekend.    We’ve done tastings and we believe we’ve discovered the secret recipe for cider success:

4 parts sweet apples
2 parts tart apples
1 part aromatic apples
1/2 part astringent apples

That combination creates a complex flavor, elegant aroma, and satisfying crisp finish.

For us, carbonating at 12 pounds per square inch for 10 days at 38 degrees F seems to create the right effervescence.      We’re very happy with the 2014 production and now know how to ramp up our efforts.     Here's the carbonation setup.

Although we’re a federal bonded winery, our state farmer winery license is still in process.   Massachusetts not only requires an extensive application backed with numerous reference documents, but it also requires a $3000 Surety bond (which we had to learn how to create - it costs about $250 for 3 years).

This weekend, we’ll begin gathering the oak logs for the 2015 Shitake inoculation.

With warmer temps we’ll restart our ivermectin injection program for the alpaca/llama to control meningeal worm.   This weekend we’ll be doing toenails and general body exams of all the animals.

Patriots Day (Monday) is a Massachusetts holiday, so we’ll use the time to plant, harvest winter lettuce, and bottle cider.     At the end of April I travel to China for a few days of teaching, so I’m filling every weekend hour with Spring farm duties.

It's great to feel the sun on my face and the dirt in my hands.  Even the alpaca are smiling.

Wednesday, April 15, 2015

A Dispatch from HIMSS

Unfortunately, I was unable to attend HIMSS this year because a special request from Andy Grove, the former CEO of Intel.  He asked me to serve with Roni Zeiger (Smart Patients, Google Health) and John Mattison (CMIO of Kaiser) as co-presenters for the first annual Marc Shuman Anti-Medical School Lecture in San Francisco, sponsored by the Grove Foundation.   When Andy calls, you listen.

My second in command at BIDMC, Manu Tandon, attended HIMSS on my behalf and sent the following analysis of the key themes he experienced.

"Interoperability is big at HIMSS in 2015.    The challenge of patient identification and finding the location of patient records are important informatics problems to solve.

I spoke to Surescripts and the CommonWell Health Alliance.   Surescripts is piloting with 3 vendors and CommonWell is embraced by many vendors.  The participating EHR system can send  a patient match request and if matched ask for list of documents available and then send a request to get documents (CCD, lab reports etc). I asked about consent – they don’t plan on storing that at the HIE level and depend on the requesting systems.  I asked Surescripts about a charge model. They are developing it.  It may be transaction based for each document received. Their current data set for 230 million patients is prescription oriented.  They would like to collect Admit/Discharge/Transfer (ADT) transactions and documents to enhance their model. They will also support the direct protocol transport functionality to send/receive ADTs.

I  spoke to Epic’s Judy Faulkner about this. She seemed supportive of the idea of a record locator service . She said they have been working on this for a year. Her view was that Surescripts has the most covered lives at the moment.  When I asked about charges she said that Epic will pass on Surescripts fees to the providers.  Epic is also still working on the consent issues.

Also, Epic is focusing on patient management solutions. They have a patient facing mobile based app for appointment scheduling, video visits, personal health device data integration and paying bills via credit cards. They also have upgraded the patient facing portal and have a bedside solution for patients to see their upcoming procedures and to communicate with their care team.

Meanwhile, over at the CommonWell booth, there was a promising demo using the CommonWell broker (Relay Health) to route FHIR transactions among three CommonWell member vendors in a pilot project that demonstrated the power of using FHIR to move discrete data instead of CCDAs.  These vendors (Cerner, McKesson, and AthenaHealth) showed near-real-time propagation of medication records and problem lists in the FHIR demo.

I can’t tell you how many vendors have the story line 'just give us your claims and financials data and we have the prettiest dashboards to show back to you'.  Several established vendors offer an Extract/Transform/Load/data model tool to collect data from administrative, financial and clinical systems to create a warehouse. Price point is $3-4 M to implement. Some smaller companies are offering services that sit on the wire and track HL7 transactions to build analytics in real time. Many are focusing on Population health. Some have shiny dashboards. Some can pull data from devices  (scales, glucometers, BP monitor) and feed analytics engines.

They is a entire area devoted to interoperability demonstrations.  There are many use cases of data transfer based on point to point exchange.  Will be interesting to study that from a scalability perspective.

I found a vendor that offers 'Enterprise Output Management'  managing printers (who can use color, follow me printing, if one goes down, divert jobs to another etc).

One vendor would like every patient and doctor to wear a tag so they can show who is where at any time.  The network team will love all that traffic.

HIMSS tracks who is in the midst of replacing their major clinical systems etc. about 170 projects going on in New England according to them.

A very busy time for CIOs."

Thursday, April 9, 2015

Unity Farm Journal - Second week of April 2015

Now that most days are above freezing and the mud is drying up, the cadence of the farm has returned to its usual pace.  

The hoop house is filled with winter/spring vegetables and all the beds have been planted.  The garlic planted before winter is sending out shoots.   The wood piles are unfrozen and woodlot management is now easier.  

This kind of flexibility means that the infrastructure work for the upcoming growing seasons can finally be done.   I’ve installed the hoses and irrigation tools we’ll need for Summer.   On the farm we use over 600 feet of hoses to bring water to the plants and animals.

I’ve done prosaic work like filling every tire on all farm equipment - mowers, wagons, wheelbarrows, pressure washer etc.   That’s a lot of tires.

April is cider bottling month and now that we have the infrastructure to carbonate and bottle sediment -free cider, we’re busy moving the cider from fermenters to Cornelius kegs inside the farm’s walk-in produce storage refrigerator.    It required significant plumbing expertise to ensure the CO2 tank is connected without leaking to 4 carbonation kegs and a bottling tool.    We’ll bottle the first 15 cases on the weekend of April 18, then let it bottle age for another 3 months before selling it, now that Unity Farm is a bonded winery.

On Sunday night, the Great Pyrenees were barking more than usual.   The warm spring weather means that animals are foraging freely every night, so I expected the usual - a coyote, a fisher cat, or raccoons.    I frequently check on the animals in the middle of the night when the barking alarm goes off.    At 3am, I opened the front door and knew in an instant what had happened.   The dogs had been playing with a skunk.    Needless to say, I’m not going to hug them for a few days.

Kathy is busy preparing new hives.    A full 10 frame deep hive can weigh 90 pounds and she often works with the bees while I’m working or traveling.   We’re shifting to 8 frame medium hives, which weigh less than 50 pounds when full.

We'll finally have a sunny weekend ahead so Kathy will do a deep dive in the hives, ensuring the bees are well fed and healthy.

It's great to be outside again without a winter coat.   Soon the trees will leaf out and we'll plant our permaculture trees - pawpaw and chestnut - as part of our plan to develop Unity Farm for the next generation of people and animals living there.

Monday, April 6, 2015

More Argonaut Deliverables

Micky Tripathi sent this update last evening.

Dear Argonaut Steering Committee Member,

I’m writing with a quick project update for your information.

FHIR DSTU2 Ballot.  The effort to keep the Argonaut-relevant components of FHIR on schedule was successful.  The FHIR DSTU2 ballot was opened on April 3, 2015.  All of the Argonaut-relevant FHIR Resources and associated DAF Profiles are complete and on the ballot.
·         Grahame’s description of the ballot decision is here:
·         A list of all of the FHIR DSTU2 implementation guides is here:
·         The current version of the Argonaut Implementation Guide is here:
·         The complete FHIR DSTU2 version for ballot is here:
·         A list of all published versions of FHIR is here:

Argonaut Testing and Implementation.  Implementation and testing efforts are picking up steam, though with everyone’s immediate focus on preparing for and attending HIMSS, we don’t expect to see intensive testing until after HIMSS, when attention will turn from FHIR DSTU1 demonstrations to Argonaut FHIR DSTU2 implementations.
·         Over 30 organizations are now registered on the testing tracking document:
·         The Argonaut reference implementation server will be updated after the HIMSS conference to include the full set of Argonaut Resources and Profiles and the first version of the Argonaut OAuth/OIDC security implementation guide.
·         After the HIMSS conference we will increase our reach out to motivate testing activities by implementation partners, who will at that point be prepared to focus their energies on Argonaut FHIR DSTU2 implementation.

Friday, April 3, 2015

The First Argonaut Deliverable

The HL7 Ballot for the Argonaut-related FHIR specifications opens today as promised.

Here's an overview with a list of the structured data elements to be exchanged through query/retrieve application program interfaces.    This approach will usher in a new era of interoperability.

Comments are welcome!

Thursday, April 2, 2015

A Meaningful Use/Certification Crosswalk

Thank you to Steve Posnack and Mike Lipinski at ONC for producing a very valuable crosswalk between the CMS Meaningful Use Rule and the ONC Certification rule.  This is not an official document and it is open for discussion.

This summary document enumerates the relationship of the proposed 2015 Edition certification criteria in three general categories:
1)      ONC’s certification program requirements (i.e., criteria a product would also need to meet to get issued a certification);
2)      the criteria proposed by CMS as applicable to EHR Incentive Programs and criteria to meet certain statutory requirements;
3)      “available” certification criteria that are neither conditions of product certification nor referenced by CMS for the EHR Incentive Programs, but could be referenced by other programs/leveraged by others if they were finalized.

Unity Farm Journal - First Week of April 2015

March has been “in like a Lion, out like a lamb”.  The snow is melted and 50 degree days mean that the growing season on the farm has started.   We’re already harvesting fresh greens from the hoop house, the peas are a foot high, and our spring transplants - cucumbers, eggplant, peppers, etc. will soon go into the hoop house.    All of the animals are in a better mood now that the snow/ice has transformed into moist warm soil.

This week the federal Alcohol and Tobacco Tax and Trade Bureau (TTB) has granted Unity Farm a permit as Bonded Winery BWN-MA-21027. Can we begin selling our hard cider?  Not quite.  Now the State wants their licensure and I’ve completed a “State Farmer Winery and Farmer’s Market license” application.  It takes real resilience to survive the multi-step process of getting every government stakeholder and regulatory body to allow a simple bottle of 5% hard cider to be sold.

As we’re preparing for commercialization, I’ve had to think about packaging and presentation.   All of our ciders to date have been carbonated naturally, which leaves a layer of sediment on the bottom of the bottle.   The first pour of the cider is clear, but the second pour is cloudy with disturbed sediment.    Given that our ciders will be moved/transported and consumed by a variety of people used to the more sanitized commercial variety, it’s time to produce cider without sediment.   There are three ways to do that

1.  Serve the cider from kegs instead of bottles so the sediment rests on the bottom of the keg and is not disturbed

2.  Carbonate the cider using a Cornelius keg and CO2, so that the process is sediment free.   Then bottling is done from the key using the Counter Pressure method which results in a clean, carbonated bottle.

3. Methode Champenoise - invert the bottle and “riddle” the yeast to the bottle neck where it can be expelled using the pressure in the bottle and flash freezing in a brine solution.

#3 is very labor intensive and #1 works for filling growlers at the farm.   I’ve decided to use #1 and #2, with bottling to be done over the next month.    Of course I will pay federal alcohol taxes (17 cents per gallon) and await state licensure before selling the cider.   Here’s a great overview of the cider laws.   

Farming requires constant learning.    Some of our fences were damaged by the tons of snow that fell over the past 3 months.    I had to learn about stringing 12.5 gauge wire, using crimp sleeves,  a crimp tool, and tighteners.     Now with the right tools and supplies I can repair any fence line.

This weekend will be spent carbonating cider, planting our broccoli seedings and planting carrots, beets, chard by seed.   I’m following our yearly calendar, anticipating the weather and doing the right activity at nature’s right time.    My September fermentations are becoming April’s carbonation and May’s bottling, a total of 8 months from apple to packaging, then additional bottle aging until Fall, selling the Fall flavors of 2014 in Fall 2015.

Wednesday, April 1, 2015

Gathering Feedback on the Certification Rule

Over the next 3 months, the HIT Standards Committee will review every detail of the 431 page Certification rule.     We’ll also be holding calls to look at the rule as a whole.  At least one call will be open to the general public.  Think of this as reviewing the “trees” and the “forest”.

In the meantime, I’m interested in the opinion of the crowd      Feel free to post comments on this blog that provide positive and negative reaction to the rule, just as Micky Tripathi and I divided the initial analysis into the Good, Bad and Ugly.

Important questions to ask

1.  The ONC Certification rule includes a catalog of many transaction types, only a few of which are related to Meaningful Use.  Is it helpful or hurtful to publish everything now in a single large regulation?

2.   Many of the standards included lack maturity per the objective ranking of their adoption.   Should regulations include standards that are not yet in use?

3.   The regulation suggests that thousands of developer hours are required for every EHR seeking Stage 3 certification.    What effect will such a burden have on the marketplace? How is innovation impacted by the rule as written?

4.  Does certification help interoperability or are there more effective means (economic incentives, culture change, penalties etc)

5.  The Certification Rule expands the enforcement powers and requirements of the ONC authorized certified bodies, and has sanctions for vendors found not to be compliant with their certification status.  Will the prescribed approach be helpful? Related to an earlier question on standards maturity, what is the balance that will need to be struck between tough enforcement and requirements for using immature standards?

Our job, as a country of stakeholders, is to strike the right balance between regulation and market forces.  Regulation is sometimes necessary when market failures occur.  Over regulation can impede market forces.    The Standards Committee and many commenters will help ONC achieve the right balance.    ONC has significantly reduced the scope of final rules in the past based on comments.   There is hope!