Thursday, July 28, 2016

Unity Farm Journal - Fifth Week of July 2016

Have you ever heard the expression, “Sweating like a pig” when someone is sweating profusely?

It’s a particularly strange statement since pigs don’t sweat much.   They have sweat glands but they are not effective, so pigs wallow in mud to keep cool.

This week in Massachusetts every day has been in the mid 90’s with heat indexes about 100F.   It’s been miserable.

Hazel Marie, our 200 pound pig, has never liked getting wet.   Before we adopted her, she lived indoors and never experienced the hot of Summer of the cold of Winter.

This week, she learned the joys of cooling off.   I started giving her cool water sponge baths, which she tolerated but did not really enjoy.    We set out a cool spray and she stood a few feet away, taking in the mist but not relishing the full stream.

Yesterday, she decided that water was her friend and now can’t get enough.   She begs us to spray her, rolls in the full stream, loving her baths.     Clearly my next farm invention needs to be a snout actuated pig shower.    Tofu, our smaller pig, still prefers his mud.




Every month on the farm has its focus.   July is a month of harvesting basil, cucumbers, peppers, blueberries, garlic, and honey.  


Farming just like gardening but on a larger scale.  Here’s what a honey tank looks like after spining a few frames.


We continue to scale up all aspects of our honey production - wax melting, spinning, settling, and bottling.

This week we let all the young guineas and chickens out of their mini-coops so they are now free ranging.   Given the hot, dry weather, we’re watching them closely since our predator load is high - there’s not much to eat in the forest at the moment, so young birds are very tempting.


Much of our evening and weekend time is spent keeping our creatures cool and hydrated.   The good news is that temperatures will drop to a comfortable 80 degrees on Friday.   We’ll continue to pray for rain!

Wednesday, July 27, 2016

The Rise of Telemedicine

As reimbursement evolves from fee for service to alternative payment models, incentives will shift from treating sickness to keeping the population healthy.   New investments will be made in technologies that reach into the home and enhance care team communication.     2016 saw an acceleration of telemedicine/telehealth.   2017 will see exponential growth.

Telemedicine is hard to define.   It could be real time video teleconferencing between clinicians (a consult), between a patient and clincian (a visit), or group to group  (tumor board discussion).    It could be the transmission of a static photograph, such as the poisonous mushroom/plant teleconsultation I do 900 times per year.    It could be secure texting to coordinate patient care.

Patients might provide care teams with objective data from devices in their homes.  Patients might answer surveys about their mood, activity, or pain.

All of these are telemedicine.

Many companies will offer cloud-based tools and technologies to support these new workflows.   Some organizations will  use bridging technology to link together every kind of endpoint (Skype, Facetime, commerical telemedicine apps) with every kind of endpoint.

There are so many use cases and so many possibilities that one approach will not serve all needs, so most organizations will have a multi-faceted strategy.

There are some unanswered questions

1.  How do you bill for telemedicine?  There is a new CPT code, but it’s not clear how it should be used.

2.  How do you address multiple conflicting state laws when consulting across borders?

3.  How is the record of a virtual encounter stored and who is the steward of the record?

For my personal telemedicine practice, toxicology consultation, I use an iPhone and email to review cases and images.   No protected healthcare information is exchanged.

I am credentialed by BIDMC for telemedicine practice

I am malpractice insured for telemedicine practice.

When consulting across state lines, I provide advice to licensed physicians in that state and never interact with patients directly (or prescribe).

I do not bill for these services, they are a public good.

Medical records are kept by the physician consulting me and that physician is the steward of the record.

As hospitals expand to serve patients at the national and international level, as payment models require more home care/wellness care, and as consumers demand the same kind of convenience  from healthcare that they get from other industries, telemedicine will expand and mature.

Telemedicine at BIDMC (part of Media Services) reports to me and I’ve requested additional staffing and investment for 2017.    Technology, business needs, and customer demand are aligning to make telemedicine an increasingly important service offering for clincians and hospitals.

Thursday, July 21, 2016

Unity Farm Journal - Fourth Week of July 2016

“Guineas for sale”

Our Guinea fowl have been especially productive, so we’ve sent this message to all the Massachusetts farm mailing lists and posted signs at all the farmstands

"Guinea Fowl Keets for Sale - 40 available now (born 7/6/16)
Sturdy vigorous baby keets, no stressful shipping involved. Locally bred hatch in many colors from healthy free range birds on a certified organic farm in Sherborn, MA
Contact Us at http://www.unityfarmstore.com/contact.html  Unity Farm LLC  ($5 each or $3 each if you purchase 10)"

At the moment, we have over 100 guineas on the farm - three mothers built a gigantic nest and hatched 40 healthy children this month.


Let us know if you want guineas on your property, keeping all your ticks under control!

We do everything we can to keep our birds healthy, including a nightly inspection to ensure they have not been injured during the daily frolics in the forest.   This week, one guinea returned to the keep with hay bale twine tangled around its legs.  Past owners of the property used haybales for erosion control but the  polypropylene twine never decomposes.  We’ve very careful around the farm to dispose of all metal, plastic, glass, and other found artifacts from previous generations.   The guinea was fine.


Our early blueberries have all been picked and sold, so we’ll take down the blueberry netting this weekend.   That’s a relief because birds, squirrels and rabbits have done their best to get into our netted areas by digging, clawing and chewing.   Every night I’ve been removing stuck creatures from our netted orchards.

We’ve been planning our Winter crops which will focus on lettuces, carrots, and spinach.  As odd as it seems, we’ll be planting all the winter crops in August so that by October they’ll be robust and healthy enough to tolerate the early freezes and diminishing sunlight.    As in previous years, we’ll harvest vegetables all winter long.

The heat in Massachusetts has been unrelenting and we’ll have 90 degree temps for the next 5 days without rain.    Every night I water the crops, fill the ponds, and ensure the animals are well hydrated.   We have a great 300 foot well which is supplied from a bog hundreds of years old.   On weekends during the Summer when I’m lifting/hauling/moving 18 hours a day, I have to be careful.   Since starting on a beta blocker one year ago to control my very occassional supraventricular tachycardia I find that I am less heat tolerant than in the past.   I’ve walked across Death Valley in the Summer at 120F without a problem, so you’d think 18 hours in a heat index of 100F in Massachusetts would not bother me.    I stay hydrated, take frequent breaks and try to stay out of the sun during the peak of the heat in the afternoon.  So far, so good.


We’ll be picking basil, cucumbers and peppers this weekend, bagging alpaca compost for sale to garden centers, and spinning honey.   Our new 21 frame  electic spinner arrives soon, so our productivity will improve immensely.

Wednesday, July 20, 2016

Care Coordination Innovation

Would you buy an iPhone if the only apps that ran on it were written by Apple?   Maybe, but the functionality would not be very diverse.

The same can be said of EHRs.   Athena, Cerner, Epic, Meditech, and self developed EHRs such as BIDMC’s webOMR are purpose-built transaction engines for capturing data.  However, it is impossible for any single vendor to provide all the innovation required by the marketplace to support new models of care  I’m a strong believer in the concept of third party modules that layer on top of traditional EHRs in the same way that apps run in the iPhone ecosystem.

There are 3 such companies doing important care coordination work in Massachusetts and we’re expecting a wide rollout of their cloud hosted modules that tightly couple with EHRs, but are not authored by EHR companies.

The Right Place, is an electronic referral and bed management platform that expedites the placement of hospitalized patients to post-acute facilities that can deliver needed services.  Unlike tools which push patient information downstream to providers, The Right Place functions more like OpenTable and Match.com.  It supports discharge planners, patient/families and post-acute care facilities by providing a “front end” solution for case managers to search/match and a “back end” bed and referral management solution for the post acute care facility.  Together, these tools provide real time data to providers on both ends that can improve outcomes, reduce unnecessary costs, and enable hospitals to track what happens to their patients after they leave the hospitals.

PatientPing enables caregivers to track and coordinate care as a patient “travels” throughout the healthcare system regardless of provider type, EHR or geography. The concept is simple.  Every time a patient visits a facility, the admit/discharge/transfer data about that encounter is sent to PatientPing servers (with appropriate privacy protection) and all appropriate caregivers/care managers are notified of the encounter in real-time. Although use cases have expanded, PatientPing's early focus was Accountable Care Organization patients appearing at skilled nursing facilities and hospitals.  This community-based approach puts the patient at the center of care and breaks down institutional silos to facilitate higher quality care at lower cost.

Collective Medical Technologies creates products (EDIE/PreManage) that are like “Facebook" for providers, including Emergency Departments. Imagine that a complex patient with a formalized care plan seeks emergency care in multiple locations. Even with health information exchange, it’s hard to coordinate all the moving parts of the healthcare system. Collective Medical creates a “wall” for each patient and ensures that licensed caregivers are “friends” on that wall. When the patient presents at the hospital, the tool pushes real-time alerts, including patient-specific risk factors, visit history, and care guidelines.  Thus, communication among caregivers can be better aggregated and visualized. One use case that has been effective in other states is the management of opioid-seeking patients visiting multiple facilities. Given the opioid crisis in Massachusetts, we’re hopeful that new tools like Collective Medical’s PreManage ED will help us better manage patient “treatment contracts”, executing care plans consistently at every emergency department in the state as part of a statewide rollout of the tool.

BIDMC has chosen to implement modular, cloud hosted services such as these in a unique way.   We’ve created a single hub for patient admit/discharge/transfer transactions hosted at the Massachusetts eHealth Collaborative.  Trusted vendors with business associate agreements can subscribe to these feeds, which are sent via HL7 version 2 messages over an encrypted transport channel.    No IT department development or resources are required to add a new trading partner.   It’s a  very scalable model.

As FHIR matures, I imagine that every hospital and clinician practice will have a curated app store of approved modules that just plug into their EHR and health information exchange infrastructure.    Some of these apps will be provider facing and some will be patient facing.      My colleagues in government understand the concept of third party innovations plugging into EHRs.   Hopefully as MACRA is refined, we'll have empowering regulation to encourage this ecosystem and move beyond Meaningful Use concepts.

Thursday, July 14, 2016

Unity Farm Journal - Third Week of July 2016

It’s the peak of summer with 90 degree temperatures and humidity that pushes the heat index to 100F.   We’re also in a drought, so we’ve had to aggressively water the orchard, berries and hoop house.      When we built all our agricultural areas we installed drip irrigation or microsprinklers as appropriate for the type of plant.    Around the farm we have 64 irrigation zones.

The cucumbers, peppers, blueberries, and basil are all ready to harvest and we’ll be bringing them to the Tilly and Salvy’s farmstand this weekend.    Our blueberries are divided into 3 separate zones - early, mid and late.    Each is covered with netting and the ripeness of the fruit is directly related to the motivation of birds to get through the netting.   This little guy - a sharp shinned hawk  got into the blueberry patch by digging underneath the netting and could not get out, so we had to carry him to safety.


There are always many raptors around Unity Farm - here’s a Cooper’s hawk watching for voles in the meadow.


As a rescue farm, we often take in animals that cannot stay in their current home.  This week, Bob arrived.  He’s a kind, gentle rooster that has such an endearing personality that the other roosters do not considering him a threat.


We’ve been finishing up the compost screening machine.   It’s very frustrating that no commericial devices to sort and screen compost are available for the small farmer.  Our finished design uses a 1725rpm motor and two sets of reduction pulleys to turn a bicycle rim at 30rpm.  It works perfectly.  Here’s a picture and a video.   The key was a lego-like Powertwist V-belts that adjust to any length.


video

We’re finishing our certification program in organic farming at Umass Stockbridge over the summer by taking Botany.   It’s been a great course thus far, with online discussions of Michael Pollan’s Botany of Desire, a review of the science of growing plants, and reflections on the human role in the life of plants.   On August 19th, we’ll graduate from the program and we can add a new credential to our degrees from Staford, Harvard, MIT, UCLA, and Tufts - a farming certificate from Umass.    You can guess which one was the most satisfying.

We'll be spinning honey this weekend, since our 30 hives are at the peak of production.    We always leave 80% for the bees.  Here's what the bee yard looks like.


This weekend, we’ll be hard at work finishing up our non-profit corporation paperwork.  Our hope is that Unity Farm Sanctuary Inc. will be approved by the IRS as a public charity so that we can ensure it provides educational services, animal rescue, and environmental preservation for generations, even beyond the lives of our family members.    We’ve completed every other government designation we’ve tried - bonded winery, organic certification, commercial kitchen, and designated agricultural property.  Let’s hope the public charity application is compelling!  Even the chickens have volunteered their time as farm hands.



Wednesday, July 13, 2016

Do We Need More or Less Healthcare IT Regulation and Legislation?

Just as I clarified last week in my post about Certification, the answer to the question “do we need more or less healthcare IT regulation and legislation” is that we need the right amount of the right regulations/legislation.

Sometimes when clinicians prescribe medication, although it does therapeutic good, it creates side effects which need to be addressed by changing a dose or by adding additional medications.

Such is the case with HITECH.   It was generally good medicine, but now that we’ve seen the side effects on workflow, clinician burden, and efficiency, there needs to be a dose adjustment.

I was recently asked to review the “Improving Health Information Technology Act” introduced by Senator Alexander in February 2016 and placed on the Senate Legislative Calendar in April 2016.   It’s intent is good - to refine existing healthcare IT legislation with fixes that enable the right amount of the right regulation.

You’ll find the summary here and the full text of the bill here.

Here’s my analysis, section by section:

“1)  Assisting Doctors and Hospitals in Improving Quality of Care for Patients

Reduces documentation burdens by convening public and private stakeholders to develop goals, a strategy, and recommendations to minimize the documentation burden on providers while maintaining quality.”

This is a good thing.   It fixes the language in HITECH which required each stage of Meaningful Use to be more stringent than the last.     That language required regulators to make each update to Meaningful Use more challenging.   The Improving Health Information Technology Act enables regulators to better balance benefit and burden.

“Allows and encourages health professionals to practice at the top of their license, allowing non-physician members of the care team to document on behalf of physicians.”

This is a good thing.   It encourages more team based care and documentation.   Using electronic systems effectively is a team sport and should leverage social networking/groupware ideas to capture electronic data.

“Encourages the certification of health information technology (HIT) for specialty providers and sites of service, like pediatric care, where more specialized technology is needed.”

As long as the Certification focuses on a few key important ideas, as noted in my previous post, this is a good thing.   One set of required functionality does not make sense for diverse software supporting specific specialties.

“2)  Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT)

Establishes an unbiased rating system for HIT products to help providers better choose HIT products.”

A government program to do this is unnecessary.   The private sector has KLAS and other companies providing such information already.

“Allows HIT users to share feedback on the user experience of specific HIT products related to security, usability, and interoperability, among other concerns.”

A government program to do this is unnecessary.   The private sector has KLAS and other companies providing such aggregations already

“3)  Information Blocking

a. Gives the Department of Health and Human Services (HHS) Office of the Inspector General the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing of electronic health information”

Although I have not personally experienced information blocking, I hear anecdotally that there are some places in the US where competing systems refuse to share data with each other.    Giving the OIG the ability to investigate is reasonable.   It’s not clear there will be much to investigate.

“4)  Interoperability

Convenes existing data sharing networks to develop a voluntary model framework and common agreement for the secure exchange of health information across existing networks to help foster bridging between networks.”

Convening stakeholders to develop a voluntary framework is reasonable.  However, I believe the private sector will do this on its own in 2016.

“Creates a digital provider directory to both facilitate exchange and allow users to verify the correct recipient.”

This is a good thing.   CMS could leverage the existing national provider identifier system.

“Requires that HHS give deference to standards developed in the private sector.”

This is a good thing.   The private sector is moving very fast to embrace simpler standards such as FHIR.

“5)  Leveraging Health Information Technology to Improve Patient Care

Requires that certified HIT exchange data with registries if registries are certified to use standards endorsed by the Office of the National Coordinator (ONC).”

There are no mature/adopted standards for registry exchange at this time.     In the interest of comprehensiveness, ONC has tended to publish/endorse standards that are not yet ready for adoption.    Registry participation should be left to the marketplace.

“Includes vendors in Patient Safety Organizations to allow for improvements in the safety and effectiveness of HIT.”

This is very reasonable

“6)  Empowering Patients and Improving Patient Access to Their Electronic Health Information

a. Supports the certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software that may update automatically.”

Although patient and family engagement is very important, it is not something that the government should certify.   Apple and other consumer companies are innovating at the speed of the market, taking us in new directions that government could not have predicted.

“Encourages the use of Health Information Exchanges to promote patient access by educating providers and clarifying misunderstandings.”

Health Information Exchanges really do not have a role in patient/family engagement.   The new approaches implemented by Apple  and other innovators directly connect the patient and provider.

“Requires HHS to clarify situations where it is permissible for providers to share patient information by providing best practices and common cases where sharing is allowed.”

Clarifying HIPAA through education is a good thing.

“7) GAO Study on Patient Matching

a. Directs the Governmental Accountability Office (GAO) to conduct a study to review methods for securely matching patient records to the correct patient. “

This is a good thing.   We are not going to be able to consolidate records across the care continuum unless we can identify the patient.

There you have it - a dose adjustment for HITECH.   Dose adjustments can have their own side effects.   Hopefully the Bill will be adjusted as suggested above before it is passed.   The goal of any new legislation/regulation, just as with medical care itself, should be to first do no harm.

Thursday, July 7, 2016

Unity Farm Journal - Second Week of July 2016

As we scale up production of fruits, vegetables, honey, mushrooms, and compost, the key to our success is automation.    It’s challenging for two people (my wife and I) to run 15 acres of organic agriculture and support 150 animals part time using only handtools and muscles.  

Last year, we produced 50 pounds of honey.   This year we’ll produce 1200 pounds

Last year, we did not sell compost.   This year, we’ll bag up 10,000 pounds

We’ve added automation slowly, only in resposne to market demand for our products.   For honey extraction, we’ve used a hand cranked centrifuge, which is great for 50 pounds.    Hand cranking 1200 pounds of honey extraction is not practical.   This year, we’re moving from a 4 frame spinner to a 21 frame electric spinner.    Given that high quality local honey sells at retail for $15-20 per pound, we should be able to recover our investment in a reasonable timeframe.

As I wrote about last week, compost production requires a trommel to screen out rocks/sticks/debris.   In the world of compost sifting, there seems to be two extremes - a hand shoveled sifter (great for 50 pounds) and a commercial screener (great for 50,000 pounds).   What do you do in the middle?  You build your own electric screener.    This week, I’ve ordered everything I need to build the screener pictured below.


Motor in a farm grade housing

Two 5/8 2.05” pulley type A

One 5/8 9.25” pulley type A

Two 5/8 pillow blocks

12” keyed 5/8 shaft 

Three Type A V-Belts

The 1725 rpm motor will be reduced to 30 rpm via the pulley system.

1725 x 2.05/9.25 * 2.05/26 = 30 rpm

With automated honey processing and automated compost sifting/bagging, Kathy and I will be able to keep our customers happy while also keeping our day jobs.

This week, the guinea fowl had 25 babies - called keets.    Guinea fowl are horrible parents and we immediately removed the keets to a brooder.   Twice a day I reached under the moms (there were 5 sitting on the communal nest) and retrieved the new hatchlings while being attacked by defensive adults.    Here’s what a guinea fowl injury looks like.   I assumed there would be an ICD10 code for that, but it seems that searching on Guinea Fowl injuries only results in industry comments about me.


This week we planted 576 basil plants - 288 in the hoop house and 288 outdoors.   There seems to be a market for bunches of basil and kitchen garden basil  pots throughout the summer.

Now that we’ve been running Unity Farm for a few years, I have a perspective about the difficulty of being a small farmer.   It’s captured beautifully in this post.

"Fungus. Blight. Weather. Pests. Parasites. Disease.

Farming is the act of living every day with the goal of keeping other things -- plants and animals -- alive. It may not be the fast-paced, dramatic lifesaving work of Emergency Department personnel, but it is work nonetheless. And it's a daily task. We don't take off a couple of days a week and decide that the plants and the animals will be fine on their own for a while. If we don't water, feed, weed, control pests -- things die. And sometimes even when we do water, feed, weed, try to control pests and disease -- things still die.

It's the hardest part.

It's the part, I think, that makes most people quit. It's the part that makes me think about quitting. It's the part that we ultimately have no control over but to do all we can and hope and pray that things work out. But sometimes they don't, and like the poem says, all we can do is dry our eyes and say, ‘maybe next year.’

That's life on the farm. "

This weekend we’ll be finishing the compost trommel, moving chickens and guineas to different levels in our brooders, and picking blueberries.    The puzzles to solve are endless and exhilerating.

Wednesday, July 6, 2016

An Alternative Proposal for Certification

Some have suggested that my comments over the past few months about the Meaningful Use program, MACRA/MIPS, and Certification imply that we should just give up - throw out the baby with the bath water.

That’s not what I’ve written.

Here’s a clarification.

I believe MACRA/MIPS is the right trajectory - create a set of desirable policy outcomes, then enable clinicians to choose technology, quality measures, and process improvements that are relevant to their practice.

Although the current MACRA formula is overly complex, it’s the right idea and I’m confident that CMS will revise the notice of proposed rulemaking appropriately.    My metric for MACRA’s success is simple - can a clinician keep three goals in mind while seeing a patient and be rewarded if successful i.e.

Ensure care is delivered in the most appropriate location in the community (urgent care, home care, rural hospital)
Focus on wellness/prevention
Avoid redundant and unnecessary testing, medications, and procedures

My issue is that MACRA currently “inherits” the flawed 2015 Certification Rule that is a kitchen sink of immature standards and a black hole for developers.   Overly zealous regulatory ambition resulted in a Rule that has basically stopped industry innovation for 24-36 months since it has listed every use case for every purpose including those unrelated to Meaningful Use and MACRA.   For vendors, every “OR” means an “AND” - developers must implement everything in the Rule because some stakeholder will demand every transaction in the regulation.   There was little curation in the Rule and most of the HIT Standards Committee recommendations to limit scope were ignored.

Here’s my recommendation for the path forward.   When the MACRA/MIPS rule is finalized it needs to reduce or eliminate dependency on the 2015 Certification Rule.  I realize that is highly unlikely because the Obama administration is drawing to a close and as of June 2016, there was not enough time for clearance processes to consider any major changes in regulations.   However, the entire HIT ecosystem is begging CMS to realize that the 2015 Certification Rule is mostly burden without benefit  - it paralyzes the industry for years without increasing interoperability.   Maybe subregulatory guidance can help diminish the role of the 2015 Certification Rule in MACRA/MIPS if regulatory change is impossible.

I’ve said this many times before, but here it is again for clarity.    There are 3 kinds of interoperability - push, pull and view.

To push data from one place to another you need a directory of endpoints (could be a provider, patient, payer, quality registry, or clinical trial database), a means (technical or policy) to trust those endpoints, and  a transmission standard to send data to an endpoint.    The right approach is to use a FHIR-based query/response for endpoint addresses, a private industry enabler for trust (such as DirectTrust, Surescripts, Commonwell etc) and a RESTful approach to push data from point to point, although the Direct protocol will suffice, given the regulatory and political history of the past 5 years.   Remember, Direct was a political compromise.  REST was always the desired technical solution.

To pull data from one place to another you need a master patient index/record locator service, a consent registry, and a query/response transaction for the data.    The right approach is to use a FHIR query/response for the master patient index/record locator service, and a FHIR query/response to request the records.   Consent can be handled in policy, technology or both.

To view data from one EHR in another EHR you need a means to identify the patient (probabilistic matching based on name/gender/data of birth or a national healthcare identifier).   You need shared authentication and authorization of trust such as OAUTH2/OpenID and a means of calling a remote viewer using a URL (a RESTful approach)

If I were King for a day, I would require certification of only 5 things

a.  Use of OAUTH2/OpenID to demonstrate an organization is a trusted exchange partner
b.  Use of a FHIR-based query to request the electronic endpoint address for a push transaction.
c.  Use of  a RESTful approach to push data to an endpoint
d.  Use of a FHIR-based query to request an enumeration of a patient’s record locations
e.  Use of a FHIR-based query to exchange the actual record (a common data set of key elements using the best available vocabulary standards)

We should limit certification to production testing of an EHR’s ability to do those 5 things.  The result would be seamless interoperability controlled by providers and patients, empowered by the vendors.

Developers would then return their programming resources to innovation and meeting their customer needs.

If Brexit taught us anything, it’s that over regulation leads to a demand for relief.

Pythagoras' Theorem has 24 words

Archimedes’ Principle has 67 words

The Ten Commandments has 179 words

The US Declaration of Independence has 1300 words

As a comparison, the 2015 Certification Rule document has 166,733 words.

As I’ve said in an earlier post, we need to step back and ask what we’ve done to ourselves.  We can be thoughtful and incremental about addressing regulatory zeal and we should start by eliminating the concept of Certification as it exists, replacing it with only 5 criteria that are easy to understand and measure.