Titanic Still Teaching us Lessons about Regulations


The Titanic is still teaching us lessons.  Titanic’s history is often retold inaccurately with regard to safety equipment.  For example, many believe that short sightedness and greed of the builders led to the shortage of lifeboats.  For the April 15th 2012 100th anniversary of the sinking of Titanic,  The Wall Street Journal took a different view in the article, “The Real Reason for the Tragedy of the Titanic”  The Journal noted that popular beliefs about the shortage of lifeboats due to cost or aesthetics weren’t correct.  Rather, outdated government regulations were to blame.  I considered the possibility that the regulatory failure that contributed to the Titanic sinking high loss of life could provide us with a lesson about health care regulations.

“This is a distressingly common problem. Governments find it easy to implement regulations but tedious to maintain existing ones—politicians gain little political benefit from updating old laws, only from introducing new laws.” – Wall Street Journal

British Board of Trade required vessels above 11,023 U.S. tons to carry 16 lifeboats. Titanic exceeded the requirements by four boats. But the ship was 46,328 tons. The Board hadn’t updated its regulations for nearly 20 years.  Chris Berg of WSJ writes that Titanic builders and designers complied with the regulatory standard of the day.  The builders tested the Transportation board “…to see whether regulators required it…” to add more lifeboats.   WSJ concludes, “Titanic’s chroniclers put moral narrative ahead of a historical one.  … British regulators assumed responsibility for lifeboat numbers and then botched that responsibility…it is hard not to see the Titanic disaster as a tragic example of government failure.”

In healthcare, politicians legislated the American Recovery and Reinvestment Act (ARRA), the HITECH Act, and the Patient Protection and Affordable Care Act (PPACA). But the responsibility to update the requirements about how HIT systems will support these mandates is held by the Office of the National Coordinator (ONC) for health and human services (HHS).  Each regulation has an extensive list of compliance requirements.

To monitor the effectiveness of these measures, we need to be collecting the right data and by analyzing the data, make course corrections when appropriate.  But the technology specifications supporting PPACA comparative effectiveness and payment reform aren’t working yet and fall short.  Few are looking closely and asking questions regarding how this technology actually supports the intent of the mandates.

Stage 2 Meaningful Use is available for public comment, but there is no information on how the interoperability standards truly collect, store and enable analysis of the right data. Illuminating this issue, I discovered that ONC Clinical Document Architecture (CDA) isn’t mature enough to specify the capture and sharing of data beyond an “encounter” or single visit of a patient by a health care provider.  There is a noble name for the current standard, a “Continuity of Care Document” or CCD.  But to truly measure effective health care, we have to measure patient wellness and track treatments over time, (“longitudinal patient records” as healthcare experts call it).  The data must be aggregated and shared in health information exchanges (HIEs) that span the continuum of care, geographies, and disparate health IT systems such as multi-vendor electronic medical records, and of course across health care providers.  The CCD standard of today doesn’t do that.  Just as the British Trade Board’s outdated regulations weren’t designed to comprehend a ship so large, the CCD isn’t designed for the larger vision of capturing enough data to measure patient health over time.

Are you surprised? I was.  If you are interested in the technical details, see this link from the web site Model-Driven Health Tools (MDHT) for CDA wherein the CCD specification clearly states regarding an Encounter, “…Shall contain exactly one…”  Make sure to search for “Encounter.”  Below is a screen shot of the document.  You’ll see the HL7, IHE, and HITSP references – these are all bodies involved with setting the standard.   This is despite the fact that the CDR in the introduction states, “…The CCR is a core data set of the most relevant administrative, demographic, and clinical information facts about a patient’s healthcare, covering one or more healthcare encounters…”

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Continuity of Care Document Specification
Continuity of Care Document Specification

Almost everyone who studies the problem agrees that longitudinal health records are beneficial, but as I look into how HHS and various standards groups within healthcare are hoping to do this, there are gaps that aren’t being addressed.  To accomplish that goal, ONC / HHS should continue the dialogue with commercial health IT companies, providers and health plans need to iterate these specifications.  The development of a standard, sharable digital XML file as a longitudinal data container, supported by electronic medical records, shared in HIE clinical networks could provide the data we need.   Just as Titanic’s vision was larger than the regulations of her day,  today we have a static standard born from regulations that won’t address the bigger vision we plan to build in healthcare.  We need to create a broader more innovative vision for continuity of care CCDs.  Defining the standard and implementing it will be  hard work that is probably best done by a small team of dedicated individuals that represent a cross-section of the health care economy.

Michael Arrigo is Managing Partner of No World Borders’ health care practice.[/fusion_builder_column][/fusion_builder_row][/fusion_builder_container]

Michael F. Arrigo

Michael Arrigo, an expert witness, and healthcare executive, brings four decades of experience in the software, financial services, and healthcare industries. In 2000, Mr. Arrigo founded No World Borders, a healthcare data, regulations, and economics firm with clients in the pharmaceutical, medical device, hospital, surgical center, physician group, diagnostic imaging, genetic testing, health I.T., and health insurance markets. His expertise spans the federal health programs Medicare and Medicaid and private insurance. He advises Medicare Advantage Organizations that provide health insurance under Part C of the Medicare Act. Mr. Arrigo serves as an expert witness regarding medical coding and billing, fraud damages, and electronic health record software for the U.S. Department of Justice. He has valued well over $1 billion in medical billings in personal injury liens, malpractice, and insurance fraud cases. The U.S. Court of Appeals considered Mr. Arrigo's opinion regarding loss amounts, vacating, and remanding sentencing in a fraud case. Mr. Arrigo provides expertise in the Medicare Secondary Payer Act, Medicare LCDs, anti-trust litigation, medical intellectual property and trade secrets, HIPAA privacy, health care electronic claim data Standards, physician compensation, Anti-Kickback Statute, Stark law, the Affordable Care Act, False Claims Act, and the ARRA HITECH Act. Arrigo advises investors on merger and acquisition (M&A) diligence in the healthcare industry on transactions cumulatively valued at over $1 billion. Mr. Arrigo spent over ten years in Silicon Valley software firms in roles from Product Manager to CEO. He was product manager for a leading-edge database technology joint venture that became commercialized as Microsoft SQL Server, Vice President of Marketing for a software company when it grew from under $2 million in revenue to a $50 million acquisition by a company now merged into Cincom Systems, hired by private equity investors to serve as Vice President of Marketing for a secure email software company until its acquisition and multi $million investor exit by a company now merged into Axway Software S.A. (Euronext: AXW.PA), and CEO of one of the first cloud-based billing software companies, licensing its technology to Citrix Systems (NASDAQ: CTXS). Later, before entering the healthcare industry, he joined Fortune 500 company Fidelity National Financial (NYSE: FNF) as a Vice President, overseeing eCommerce solutions for the mortgage banking industry. While serving as a Vice President at Fortune 500 company First American Financial (NYSE: FAF), he oversaw eCommerce and regulatory compliance technology initiatives for the top ten mortgage banks and led the Sarbanes Oxley Act Section 302 internal controls I.T. audit for the company, supporting Section 404 of the Sarbanes Oxley Act. Mr. Arrigo earned his Bachelor of Science in Business Administration from the University of Southern California. Before that, he studied computer science, statistics, and economics at the University of California, Irvine. His post-graduate studies include biomedical ethics at Harvard Medical School, biomedical informatics at Stanford Medical School, blockchain and crypto-economics at the Massachusetts Institute of Technology, and training as a Certified Professional Medical Auditor (CPMA). Mr. Arrigo is qualified to serve as a director due to his experience in healthcare data, regulations, and economics, his leadership roles in software and financial services public companies, and his healthcare M&A diligence and public company regulatory experience. Mr. Arrigo is quoted in The Wall Street Journal, Fortune Magazine, Kaiser Health News, Consumer Affairs, National Public Radio (NPR), NBC News Houston, USA Today / Milwaukee Journal Sentinel, Medical Economics, Capitol ForumThe Daily Beast, the Lund Report, Inside Higher Ed, New England Psychologist, and other press and media outlets. He authored a peer-reviewed article regarding clinical documentation quality to support accurate medical coding, billing, and good patient care, published by Healthcare Financial Management Association (HFMA) and published in Healthcare I.T. News. Mr. Arrigo serves as a member of the board of directors of a publicly traded company in the healthcare and data analytics industry, where his duties include: member, audit committee; chair, compensation committee; member, special committee.

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