Cool Technology of the Week

I've written several posts about BIDMC's use of "private cloud" approaches to host electronic records and gather community-wide quality data.   Healthcare organizations have avoided the use of "public cloud"  because of HIPAA/HITECH privacy concerns, lack of breach indemnification/data integrity guarantees, and the unwillingness of many cloud providers to sign business associate agreements.

Although it has not been widely discussed in the industry, the Centers for Disease Control and Prevention's (CDC) Biosense 2.0 initiative has done ground breaking work to solve these issues, using Amazon's AWS GovCloud to create a national repository of syndromic surveillance data that includes all the protections needed to protect privacy including independent security testing at the FISMA-Moderate Level.

CDC is the first government agency to complete all the rigorous certification needed to host sensitive data in the public cloud.

CDC has also built gateways that make it easy for public health departments to submit data to the cloud - a Direct Project adapter, an NwHIN Exchange adapter, and others.    Meaningful Use Stage 1 requires the testing of health information exchange with public health and Beth Israel Deaconess did its transactions with the Boston Public Health Commission (BPHC), which stored them in CDC's public cloud.  BPHC was the first public health department in the nation to provide data feeds to the Amazon infrastructure.

Finally, CDC has enabled queries of the cloud data using multiple platforms including open source analytical tools such as R.

A secure, HIPAA-compliant public cloud that includes healthcare information exchange gateways and analytical tools.   That's cool!

Our Cancer Journey Week 17

Although Kathy's body is sore and her hands/feet are numb, her mood is good as we finalize our house sale, pick out the chickens we'll raise on the new farm, and prepare for the life ahead instead of looking back on our old life and the events of the past 5 months.

She lost her last eyebrow hairs this week and the toenails on her big toes will likely fall off soon.   She cannot open jars or water bottles because of diminished grip strength and today she visits the orthopedist for followup of her probable right knee medial collateral ligament tear.  But she's happy.

The chickens we've decided to raise are Buff Orpingtons, Jersey Giants, and Brahmas  - all docile large breeds.    We'll likely raise a small number to start with, ensuring we learn chicken care incrementally.   We have local farms and grain mills as well as web-based chicken farming resources to help us.   This Summer, we'll build a portable chicken tractor, then design a permanent coop for Winter.

Just 4 more treatments of Taxol and then hopefully Kathy's weakness/numbness will resolve as we move onto surgery and radiation.

Milestones ahead - films/orthopedic examination today, MRI of the breast on April 25 to determine if any detectable tumor remains, then a breast surgeon appointment on May 31.   Although lumpectomy is a long shot and mastectomy is likely, Kathy's response to chemotherapy has been so good, that there's a possibility for minor rather than major surgery.   We'll know by June, just about the time our chickens will be old enough to enjoy the long Summer days outside in our meadow.

Clinical Query, I2B2, and QueryHealth

Today I'm presenting an overview of our new clinical trials/clinical research business intelligence system, called Clinical Query to the BIDMC Chiefs and Vice Presidents.

Here are the slides I'll use.

The principle behind Clinical Query is that investigators will want to ask questions, preliminary to research, that will help them understand the potential statistical power of a clinical trial or the availability of data for clinical research.

What did we do?

We loaded 2.2 million patients (1997 to the present) and 200 million data elements into a repository,  ensuring that every data element was mapped to a controlled vocabulary.  When then built a web-based query tool capable of navigating 20,000 medical concepts via boolean (AND/OR) expressions of arbitrary complexity.

Labs were mapped to LOINC codes.

Problems/Encounter Diagnoses were mapped to SNOMED-CT codes.

Medications and Allergies were mapped to RxNorm codes

Demographics were mapped to the same code sets required for Meaningful Use.

The result is that any authorized user, who has completed our institutional HIPAA training, can run real time population queries.

For example, since my wife has Breast Cancer and has taken Ace Inhibitors, maybe I want to study the association of the two and I need a cohort of potential subjects.    The query from start to finish took 3 seconds and yielded 2421 +/- 3 patients.

Why +/- 3?

We never report the exact number to ensure that the privacy of individual patients is protected since I could create a query so arcane that it identifies a single individual.   The fictional example I've used in lectures is: "my neighbor has one blue and one green eye.   Show me the count of all blue-eyed, green-eyed people taking mental health medications."  A count of 1 could be disclosing.    By adding arbitrary numbers to every result we ensure that population queries remain ambiguous.

The BIDMC and Harvard-wide Institutional Review Boards (IRB) decided that aggregate de-identified queries, preliminary to research, may be done by authorized, trained users without requiring IRB approval.

Additional data extraction that would be used as part of offering a clinical trial or clinical research opportunity to a patient does require IRB approval.

Many novel explorations are possible such as the fact that 80,000 patients had ischemic heart disease and no history of Vioxx use, while 800 patients had ischemic heart disease and took Vioxx, which was withdrawn from the market in 2004 because of concerns about increased risk of heart attack and stroke with long-term, high-dosage use.   Clinical Query can help investigators explore the temporal relationship between the introduction of Vioxx and the frequency of ischemic heart disease.

Clinical Query is based on the I2B2 Standards for aggregate query/response of clinical data bases.   Over 60 hospitals have implemented I2B2 applications, often in support of the Clinical and Translational Science Awards (CTSA).

I've written about the QueryHealth initiative which is using HL7 Health Quality Measures Format (HQMF) to query heterogeneous data sources.

What if the QueryHealth initiative could access I2B2 connected data sources, such as enabling pharmaco-vigilance queries from the FDA to be broadcast across the country?

We can best protect privacy by keeping all our patient identified data inside our data center and responding to external queries from payers, government agencies, and public health with aggregate numbers.   Reporting on the number of patients taking Vioxx and the number of patients presenting with chest pain without submitting patient identified data to external registries minimizes risk.

We'll explore the intersection of QueryHealth and I2B2 at BIDMC in the upcoming months and I'll write about that, just as I wrote about our PopHealth lessons learned.

I've written about our efforts to Free the Data and create a learning healthcare system.    Today marks a milestone for enabling our data to be explored with Clinical Query while protecting the security and integrity of our enterprise registries and repositories.

What Keeps Me Up at Night 2012

I've written several posts about the issues that keep me up at night.  Here's what I wrote in 2011.

Today, my team presented a list of risks to the Compliance, Audit and Risk Committee at BIDMC.   Here's my list of top risks for 2012:

1.  Old Internet browsers - many vended clinical applications require specific versions of older browsers such as Internet Explorer 6, which are known to have security flaws.  We've worked diligently to eliminate, upgrade or replace applications with browser specificity.   At this point we are 96% Internet Explorer 8/Firefox 7/Safari 5 minimizing our risks to the extent possible.

2.  Local Administrative rights - Of our 18,000 devices on the network, a few thousand are devices that require the user to have local administrative rights to run their niche applications (often the research community doing cutting edge research with open source or self developed software).   We have done everything possible to eliminate Local Administrative rights on our managed devices.

3.  Outbound transmissions - Security has historically focused on blocking evil actors from the internet.   Given the current challenges of malware and infections brought in from the outside, it's equally critical to block unexpected outbound activity.

4.  Public facing websites -  any machine that touches the internet has the potential to be targeted for attack.  We've implemented proxy servers/web application firewalls on most public websites.

5.  Identity and Access management - Managing the ever changing roles and rights of individuals in a large complex organization with many partners/affiliates is challenging.  If an affiliate asks for access to an application, how do you automatically deactivate accounts when users leave an affiliate, given the lack of direct employment relationships?

6.  Anti-virus - the best anti-virus applications only catch about 50% of malware.  Thus, a multi-layered defense is required.  However, adding all those layers impacts performance and can result in false positives.   Balancing security, reliability, and performance is challenging.

7.  Security awareness - When that phishing email arrives asking users for their username/password, social security number, and a DNA sample, some people still fall for it.   Many users surf sites that are known virus distribution sites.   Even social networking is a vector for malware.

8.  Keystroke loggers and screen scrapers - mobile devices and home computers beyond IT control may contain keystroke loggers that capture user credentials, bypassing encryption, VPNs, and other layers of security.

9.  Forensics -  increasingly sophisticated security infrastructure implies more events to research which requires additional staff that are challenging to find, recruit and retain.

10.  Third party desktop software - it's no longer the operating system that presents the greatest risk, but security holes in Java and Adobe products such as Flash.

Security is journey and you'll never be done.  The hope is that your risk profile improves over time as more  of the environment is locked down, creating a restrictive rather than permissive infrastructure which makes services available by exception to the minimum extent necessary while balancing security and ease of use.   As I've said before, this is a Cold War at a time when Meaningful Use encourages more data sharing and breach reporting/regulatory penalties are increasingly severe.   All you can do is your best, given fixed resources and time.   And try to get some sleep.

The Medicare Electronic Prescribing Incentive Program and Meaningful Use

I was recently asked by BIDMC clinical leaders to describe the difference between the Medicare Electronic Prescribing Incentive Program and the Meaningful Use Stage 1 core requirement to e-Prescribe.

Some clinicians are receiving Medicare penalties/fee reductions even though they have achieved the much more rigorous Meaningful Use requirements.

The Medicare Electronic Prescribing Incentive Program and Meaningful Use are two separate initiatives with two separate requirements, although both promote the use of electronic prescribing through the use of incentives and payment adjustments.

The Medicare Electronic Prescribing Incentive Program promotes electronic prescribing by requiring that an eligible professional report the electronic prescribing activities using G-codes in billing claims for 10 encounters per year.

The Meaningful Use Stage 1 requirements promote electronic prescribing by requiring that clinicians meet an electronic prescribing objective by electronically prescribing at least 40% of permissible prescriptions.

Beginning 2012, Congress authorized payment adjustments for clinicians who did not become successful electronic prescribers under the Medicare Electronic Prescribing Incentive Program .  The 2011 Medicare Physician Fee Schedule outlined the requirements to avoid the 2012 payment adjustment.   Eligible professionals were required to report the electronic prescribing measure using the G8553 g-code via claims for at least 10 unique visits where the clinician generated an electronic prescription from Jan. 1, 2011 – June 30, 2011.

Since Meaningful Use does not require claims-based reporting of e-prescribing,  it is possible that clinicians could have achieved Meaningful Use but still been subject to the 2012 eRx payment adjustment.

Clinicians cannot receive incentives under both programs, but they can be penalized under the Medicare Electronic Prescribing Incentive Program.   The AMA produced a useful guide to incentives and penalties.

The Medicare Electronic Prescribing program applies to 2013 and 2014 and then will end.   Thus, make sure you enter your G-codes for 10 encounters that included e-prescribing even if you have attested for Meaningful Use.   That way, you'll avoid the penalties.