Shortcut: to respond to this Federal request, go to this post on the government’s blog.

Update 9 a.m. 6/19: Josh Seidman, author of this post, says there’s no specific deadline; these comments will feed into HITPC )the Health IT Policy Committee), which deliberates as long as it needs, but “the sooner the better.”

Numerous times in the past two years this blog and this Society have contributed significantly to the Meaningful Use regulations that have substantially changed the landscape, the outlook, for patients who want to be engaged in their care. SPM Policy Chair David Harlow has led several projects to compile members’ views into a unified response. (Search his name on this site to see his many contributions.)

Now the time has come. This time it’s about information you have and data you create: how can you make sure they’re in the record? How should such information be used in tracking your health and in medical decision making?

Specifically, what should be in the regulations for Meaningful Use, Stage 3, to make information you have be a functioning part of your healthcare records?

Examples that come quickly to mind:

• When my wife first gave birth, her penicillin allergy was missing from her record, and they tried to give her some. Could have had serious consequences. That’s information she had, which was not in the record. 
• A while back at a dinner I met the wife of a hospital executive. She said “I cannot get my husband’s own hospital to fix a wrong medication in my record! This has been going on for two years!” Again, she has the right information but it’s wrong in the record.
• Then there’s all the self-generated data from the Quantified Self movement: Fitbit pedometers, Zeo sleep monitors, Withings blood pressure devices, and many other devices: should EHR vendors be required to accept these data streams? (Why?)

That’s just the tip of the iceberg; I’m really impressed with the thinking that’s gone into this. Here are the bullet points from the blog post; italics are my two cents’ worth of comments:

• How can we ensure that patients’ reports of symptoms and their knowledge of their own contraindications make their way into EHRs?
• In other words, if you report that you have a symptom or an allergy, should we have regulations to require that it get into the record? How fast?
• Although there clearly is a need to have a structure for PGHD [patient-generated health data], does all PGHD for care management need to be in a structured form?
• Generally speaking, structured data is in a form a computer can understand; unstructured data is just plain text notes, which is almost certainly what your doctor currently enters. (The classic version of “unstructured data” is paper notes!)
• In order to manage the legal, policy, and operational issues associated with provider collection of PGHD, what should individual providers do to ensure they have a plan for managing that data?
• Patients – particularly those living with chronic conditions [e.g. diabetes, or Hugo Campos’s defibrillator] – have an ongoing stream of information, for which clinical encounters with the delivery system are infrequent data points. What is the relationship between that data stream and the EHR?
• Another, simpler, low-tech example is the stream of weight data from the bathroom scale of a patient with CHF [congestive heart failure, in which the weight from retained fluid is a major measure of health maintenance]
• Although PGHD has some specific needs, identification and sourcing of all data sources are important; how can addressing PGHD management issues help clarify how data sources are tagged more generally in the EHR?
• This is a sophisticated view. Providers have often worried aloud about whether patient-entered data will be reliable, and how to keep it clearly identified; this item notes that it’s just as important to know how provider-entered data got into the system. For all cases, how should this be done?
• For which health issues is it clear that patients and families are the authoritative source?
• This one’s new to me – it’s a little bit mind-bending.
• How should we balance the need to build in the capability for providers to incorporate structured PGHD into the EHR without being overly prescriptive?
• In simpler language: we know we need to require including this data; but how do we require it without making too many rules and restricting useful flexibility? 
• Similarly, how should we balance the concern about being overly prescriptive with ensuring a certain degree of interoperability, usability and understandability of PGHD?
• We want to require that EHR data must be usable, and understandable, and that it can be moved between systems, at least to some extent. 
• What important implications does PGHD have for the robustness of clinical decision support, quality measurement, and care coordination?
• How can collection of PGHD address health disparities and what cautions exist to ensure that disparities are not widened?
• “Disparities” refers to the reality of unequal care for non-whites or poor people or rural people or women or anything else. One commonly cited example is the digital divide – people who don’t have broadband or smartphones. Another is people who don’t have health insurance or a regular provider of care: their case is new to every clinician who sees them.

Again, to comment, go to this post on the FACA blog.

(I don’t yet know the deadline for comments.)