Off to the Highlands

I'm in Scotland for a few days lecturing at the University of Dundee near Edinburgh.

My colleagues in Scotland and I have much to discuss about healthcare technology and policy.   I'll summarize my lessons learned next week.

Tomorrow a small group of us will climb some of the highest peaks in the UK   - Aoneach Eagach and Ben Nevis.   They're known for their uniquely bad weather (171 inches of rain per year), high winds, and challenging trails.

I've packed my total body Gortex and my lightweight Treksta Gortex boots.   Here's a complete list of my gear for the Scottish Highlands

Boots
 Treksta Evoltion Mid (Gortex)

Socks
 Injinji Crew
 Outdoor Research Verglas Gaiters (Gortex)

Pants
 Arcteryx Rho LT
 Arcteryx Alpha SL (Gortex)

Shirts
 Arcteryx Phase SL
 Arcteryx Phase AR

Jackets
 Arcteryx Celeris windshell
 Arcteryx Alpha LT (Gortex)
 Arcteryx Solo Belay Jacket

Gloves
  Outdoor Research PL400
  Outdoor Research Endeavor Mitts (Gortex)

Headwear
  Outdoor Research Option Balaclava
  Outdoor Research Winter trek hat
  Outdoor Research Drifter cap (Gortex)

Other gear
  Petzl e+lite
  Small First aid kit
  Black Diamond Shot climbing pack
  Platypus 2L water reservoir
  Pro-Bars (they're vegan)
  Prescription polarized sunglasses

I'm off to the Highlands and will post pictures of the summits.

Building Birdhouses

When my wife and I created our community garden we installed birdfeeders (sunflower and thistle) and birdhouses to support the birds that nest in our area.     I built the bird houses from a single length of 1x6 cedar from Home Depot using these simple plans.  Just 5 cuts with a Japanese handsaw, a few finishing nails and they were ready for mounting.   Birds moved in within hours.

Here's a photo of a cedar bluebird birdhouse, ready to be installed.

Here's another great site with house blueprints for several bird species.

My next project is a tree-mounted house for

Black-capped Chickadees
Carolina Chickadees
Mountain Chickadees
Chestnut-backed Chickadees
Boreal Chickadees
Siberian Chickadees
House Wrens
Carolina Wrens
Bewick's Wrens
Winter Wrens
Prothonotary Warblers
Tree Swallows
Violet-green Swallows
Tufted Titmouse
Plain Titmouse
White-breasted Nuthatch
Red-breasted Nuthatch
Brown-headed Nuthatch
Pygmy Nuthatch
Brown Creeper

 I highly recommend building cedar birdhouses with hand tools.  It's great therapy.

Meaningful Use Payments Arrive

HITECH Incentive payments began on May 19, four weeks after attestation for Meaningful Use became available. 

On May 19, BIDMC received the following electronic funds transfer from CMS/Medicare:

CORPORATE TRADE PAYMENT CREDIT
CMS (EHR INCENT) DES:HITECH PMT ID:

BIDMC was the first hospital in the country to attest to meaningful use and received payment from CMS on the first day of stimulus disbursements.   Hospital payments start with a $2 million base payment.  Per the CMS FAQ 

"Eligible hospitals and CAHs will receive an initial payment and a final payment. Eligible hospitals and Critical Access Hospitals that attest in April can receive their initial payment as early as May 2011. Final payment will be determined at the time of settling the hospital cost report."

Although we received an initial $2 million dollar payment, we have not received information about the final payment calculation or timing.

Some have worried that attesting early will create a timeline for stage 2 that is challenging to meet i.e.

Standards Committee work for stage 2 will be done by September 2011
ONC proposed regulations will be drafted in the Fall, released in December and will become final in mid 2012
The Stage 2 meaningful use demonstration period begins October 1, 2012

The likelihood that regulations can be transformed into working, implemented software by October 1, 2012 is slim.

Hence the HIT Policy Committee will likely recommend that Meaningful Use Stage 2 be deferred a year, meaning that the demonstration period for those who attest to stage 1 in 2011 will be moved to October 1, 2013.

Based on everything I know, here's the workplan I'd recommend for IT departments
1.  In 2011, update your purchased products as needed to implement meaningful use versions
2.  In 2011, if your systems are built rather than bought (or are a combination of the two), use the CCHIT EACH program to certify your site as needed for hospital and ambulatory certification criteria.
3.  In 2011, educate your clinicians and measure meaningful use metrics for a 90 day demonstration period.  Note that this can be done in parallel with certification, since systems only need to be certified by the end of the demonstration period
4.  In 2011, collect your initial meaningful use payments
5.  In 2011, work on X12 5010 for the January 1, 2012 deadline
6.  In 2011, begin ICD10 planning for the October 1, 2013 deadline.   I believe this deadline will be extended.
7.  In 2012,  plan on beginning your Meaningful Use stage 2 measurement period on October 1, 2013.

A lot going on in parallel, but by taking it one day at time, step by step, it's doable.

A Strawman HIE Directory Solution

At the May HIT Standards Committee, we discussed the standards which support entity-level (organization) provider directories (ELPDs) in healthcare information exchanges.

The business requirements suggested by the HIT Policy Committee's work (the table below) require federated query/response transactions to a single, nationwide enterprise level provider directory, specifically

1)    Support directed exchanges (send/receive as well as query/retrieve)
2)    Provide basic “discoverability” of entity – including demographic information
3)    Provide basic “discoverability” of exchange services (e.g., CCD, HL7 2.xx)
4)    Provide basic “discoverability” of entity’s security credentials

When we presented the currently available standards - DSML for the schema, LDAP/ISO for the query vocabulary, REST/SOAP for the transport, and LDAP for the query language, the response from the HIT Standards Committee was that the combination of these standards as specified in the IHE HPD profile was largely untested in production.

Our conclusion was to revisit the business requirements with the HIT Policy Committee with the hope that we could devise a workflow enabling existing, mature standards, such as DNS, to be used for provider directories.

The presentation by the Privacy and Security Workgroup included this summary of how the existing NwHIN exchanges – Direct and Exchange – provide the required services.

One possible avenue for moving forward might be to build upon the Direct Project’s work to enable the Domain Name Service (DNS) to be used as the federated service for discovering entities and their security credentials.  I recently learned about an idea that Paul Egerman has suggested to the ONC:  the possibility of creating a top-level domain for the health industry.  Putting those two ideas together,
here is a strawman that would move us forward.

1.  The ELPD should be a single, national data structure that is accessible by EHR systems.    Accessibility needs to include the capability to have a local cache.

2.  A national ELPD could be achieved through the use of a top-level domain for the health industry (e.g., .HEALTH), instead of  GOV, EDU, COM, MIL, ORG, and NET to designate entities participating in healthcare information exchange.

With a .HEALTH top-level domain there could be a defined set of registrars who are authorized to issue .HEALTH domain names.   The benefits of doing this include:

Financial - The business model for registrars is already established, while there is no business model for other approaches being explored.

Leverages Existing Software Capabilities - The software for registering entities and making updates for domain names is well established.  The use of DNS is well-known and can easily handle a national entity directory.    DNS (along with "WhoIs") can be used by EHR systems.

Security - We could restrict query of the .HEALTH domain to other members of the .HEALTH domain, reducing its vulnerability to denial of service attacks and spamming.

3.  The ELPD would embrace the Direct Project's implementation guide for storing digital certificates in, and retrieving digital certificates from, DNS.

As for the HIT Policy Committee’s request for standards supporting the discovery of demographic information and exchange capabilities, that functionality could be achieved using a decentralized approach.     For example, the Standards Committee could specify that each organization needs to have a Uniform Resource Identifier (URI) where they list additional information about their organization, including their health information exchange send and receive capabilities (e.g. http://www.bidmc.HEALTH/services).    Such an approach would be easy to maintain and would be extensible.

Thus, rather than try to invent new standards, processes, and business models, let's leverage the basic standards of the internet -a top-level domain, DNS, and URIs to create the Directory Services we need to enable Health Information Exchange.

As a next step, the Privacy and Security Workgroup will consider the possibilities of this strawman.

Based on the guiding principles for the HIT Standards Committee articulated in the first meetings of the committee - keep it simple, do not let perfection be the enemy of the good, design for the little guy, leverage the internet, and keep the burden/cost of implementation low, I'm convinced the notion of using a top-level domain, existing DNS standards and URIs to support health information exchange directories is worthy of serious consideration.

Medical Device Data Systems

In February, the FDA issued an important rule on Medical Device Data Systems (MDDSs), categorizing them as subject to FDA Class I general controls.

What is an MDDSs?
MDDSs are data systems that transfer, store, convert according to preset specifications, or display medical device data without controlling or altering the function or parameters of any connected medical device—that is, any other device with which the MDDS shares data or from which the MDDS receives data.

What are FDA Device categories?
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 301 et seq.) establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). General controls include requirements for registration, listing, adverse event reporting, and good manufacturing practice (quality system requirements) (21 U.S.C. 360c(a)(1)(A)). Special controls are controls that, in addition to general controls, are applicable to a class II device to help provide reasonable assurance of that device’s safety and effectiveness (21 U.S.C. 360c(a)(1)(B)).

A member of the legal community wrote me:

"John:  I have been getting up to speed on the recent FDA rule governing Medical Device Data Systems.  This rule would appear to regulate the development of  interfaces between medical devices and hospital information systems.  Have you or anyone on your team looked at this issue? "

I consulted one of the leading HIT vendors, which responded

"John: We have indeed studied the MDDS rule and after much deliberation, it does appear that vendor or healthcare organization developed black boxes or interfaces which store or transport data from a medical device to another database for use in clinical decision making, fall into the category of MDDS. (The EHR itself does is NOT fall into this designation).

We are preparing to register with FDA a series of interfaces such
as the following:

Lab Instrument results interface
Radiology/Cardiology PACS interfaces
Hemodynamic monitor interface
Dynamap interface
etc

The good news is that there are no 510K filings required but you do need to show that you follow Quality Management System protocols, such as ISO. We recently got ISO 9001:2008 certified in anticipation  of more and more FDA regulations coming our way."

The regulation does include a review of the scope of the MDDS definition and notes CPOE and e-Prescribing are not MDDSs.   However, the regulation should be studied by vendors and hospitals who build systems to identify the applications and modules that require registration with the FDA, adverse event reporting and possible organizational ISO 9001 certification as evidence of quality management.

The regulation strikes an interesting balance - how to encourage innovation while also requiring accountability for errors that result from software or hardware defects.

Definitely worth a read to ensure you are compliant!

An FAQ on Exchanging Key Clinical Information

Yesterday, CMS posted an important FAQ clarifying the Meaningful Use requirement to exchange key clinical information.

Since the Standards and Certification final rule does not include any transport standards and no EHR has been tested or certified to comply with any particular transport capability, it was unclear how the CCDs/CCRs produced by certified EHRs should be exchanged as required to attest for meaningful use.

The CMS FAQ suggests that the exchange must be accomplished over an electronic network and not using fixed media:

"No, the use of physical media such as a CD-ROM, a USB or hard drive, or other formats to exchange key clinical information would not utilize the certification capability of certified EHR technology to electronically transmit the information, and therefore would not meet the measure of this objective"

Here's my advice - do an exchange of a single CCD/CCR via a secure website, secure FTP or secure email and you'll be fine.

Although 1) certification focused on content and vocabulary standards, not transport standards and 2) certified EHRs will not be able to tell the difference between a CCD/CCR received via a network or exchanged on media, CMS has given us guidance.   Also, it's a best practice to avoid the use of media for protected health information,  because having clinical data on mobile media is a security risk as noted by the OIG report.

How Do Vegans Get Enough Protein?

As a vegan, one of the more frequent questions I'm asked is "if you eat only plants, how do you get enough protein?"

A recent movie review of Forks Over Knives in the Boston Globe speculated that vegans must have a hard time with protein and essential nutrients.

Somehow the average consumer has forgotten that plants are filled with protein (i.e. have you ever heard the term "textured vegetable protein"?)

As a vegan for over 10 years, I've never had any issues with protein, necessary amino acids, or essential nutrients.  I get everything I need from  a simple balanced diet that includes protein rich plants such as spinach, soy, and peanuts.

Here's a useful resource about the protein content in vegetables.

How do vegans get enough protein?  Just pass the spinach!

Here's a few favorite protein rich recipes.

About the only issue vegans have is getting enough B12.   I need about a thimbleful per year!  I can just get it from B12 found naturally in the topsoil that sticks to root vegetables (no matter how much you clean them) or take an occasional supplement extracted from yeast.

No meat, milk, or cheese required!