Site moved to, redirecting in 1 second...

« April 2012 | Main | June 2012 »

5 posts from May 2012

May 16, 2012

Health Law 2.0 Session at Health 2.0 Spring Fling - Boston

Health Law 2.0

The Health Law Session at Spring Fling 2012 - Health 2.0 Matchpoint Boston

Storified by David Harlow � Wed, May 16 2012 15:09:42

On Monday, May 14, 2012, The Health Law 2.0 session kicked off Health 2.0's Spring Fling in Boston. Some tweets from the session will give you a taste of the issues we discussed: telemedicine; fraud and abuse; privacy, security and data breach notification rules under HIPAA and HITECH; regulation of mobile health apps by the FDA and other agencies.  We packed a lot into a one-hour session and enjoyed engaging with the attendees on these issues.

First, the advance press:

David Harlow will be speaking during our special Health 2.0 Law session in Boston. First, he answers some... 2.0
And then the tweets from the session itself:
Getting started with Health Law 2.0 at #health2con. Ft @healthblawg. @boltyboy notes that startups don't always understand the rules/regs.Nate Osit
No PowerPoint slides in opening legal talk - gutsy move :) #Health2ConAccessMD
Patient initiatives- how do we reach patients who live in rural areas, have rare conditions, and others? #health2conNate Osit
Karie Rego kicks off Health Law 2.0 @ #health2con w quick overview of #telehealth issuesDavid Harlow
@healthblawg live tweeting while on the panel. Health 2.0 at its finest! #health2conNate Osit
When it comes to the law, prevention is the way to go. - Jack Eiferman #health2conHealthcare Heroes
Brian French of @NixonPeabodyLLP talks about the Antikickback Statute #health2conHealth 2.0
Rego gave an amazing case for the rarity of experts in the MD community, particularly in pediatric care. Huge motivator for us! #Health2ConAccessMD
Q- how can you incentivize without getting in trouble? A- Define purpose, avoid incentivizing HHS service utilization. #health2conNate Osit
More you can document up front, the better. Define mission, scope, services. Reduces risk. #health2con #healthlawForerun, Inc.
Health Law 2.0: Pay people to get better. Sounds good but fraud and abuse laws could make that challenging. #health2conHealthcare Heroes
HealthLaw2.0 takeaway - Document early, review federal safe-harbors, and review state laws #health2conChristopher Carter
David Harlow - medicine used to take place in the hospital ... Now it happens in your phone #Health2ConAccessMD
@healthblawg discussing regulation of mobile apps. Will FDA regulate apps, EHRs, mobile health space? Seems to be moving there. #health2conNate Osit
RT @NateOsit: Apps that connect/replace med devices may be subject to regulation or review by FDA. #health2conElin Silveous
RT @NateOsit: Got something new? That'll be 2 years and $2mil. Improving something? That'll be a couple hundred K and 6 months. #health2conHealth 2.0
Jack Eiferman: Is there a crosswalk that explains everything? The answer is no #health2conHealth 2.0
#health2con kickback statutes falsely named: it felonizes other industries' typical vendor-client relations (dinners out, etc) in some casesDon Fluckinger
#health2con #HIPAA Understand what kind of info you're handling: PHI vs PII (personally identifiable info) and neither (user generated)Don Fluckinger
RT @health2con: Rego: Work with companies that mirror your level of risk #health2conHealthcare Heroes
Dan Orenstein's tips: encrypt data, deidentify information, use a standard business associate agreement #health2conHealth 2.0
Even if you aren't hipaa-regulated, it can be a huge advantage to build as if you were #Health2ConAccessMD
@athenahealth resistant to encryption of data at rest. Worried about performance issues. #health2con #healthITNate Osit
#health2con Good health law panel. Succinct and informative.Joe Cross
Great session on Health 2.0 law! Summary- even if you're not covered by #HIPAA, act as though you are. #health2conForerun, Inc.
Standing room only in this pic! RT @healthblawg: Health Law 2.0 audience ... #health2con Sevilla, MD
We got some follow-up press as well, from the in-house organ and others ...
Health 2.0 Law: What is and isn't in writing. Recap of panel at #health2con | Health 2.0 News 2.0
Interesting RT @EHRIntel: What does safe harbor mean for health IT? #health2con #healthIT #healthLawColin Hung
Docs should be wary of anti-kickback laws when implementing HIT - FierceHealthIT: G. Self
For the rest of the tweetstream from the Health 2.0 Spring Fling: 
FROM THE BLOG Health 2.0 Spring Fling 2012 Tweetstream, Starting with Health Law 2.0 Harlow

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

May 13, 2012

Health 2.0 Spring Fling 2012 Tweetstream, Starting with Health Law 2.0

Health 2.0 Spring Fling comes to Boston this week.  The pre-conference code-a-thon is already history. I'm going to help kick things off with a Health Law 2.0 session on Monday.  For those who'd like to follow along at home Monday and Tuesday, here's the tweetstream; the hashtag is #health2con.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

May 08, 2012

In the press recently - Health care law and policy issues ... & some upcoming conferences

Here's a sampling of some recent press, touching on the diversity of issues that I've been dealing with these days:

Supreme Court Hears Arguments on Health Reform Law, Nation Awaits Decision  We're counting down to a decision in late spring/early summer ... and I read today that oddsmakers are giving the law's opponents a slight edge.

Smart Social Media Policy for Healthcare  I've been working with health care providers on social media issues from a variety of perspectives; this article from is focused on the employment-related issues that arise from health care organizations' employees' use of social media.  

Health Law 2.0: Data exchange spurs HIT compliance challenges  I'll be chairing a Health Law 2.0 panel at the upcoming Health 2.0 Spring Fling in Boston; the pace of change in this arena continues to be rapid, and the question is always how to fit innovation within the regulatory structures unique to health care.

I look forward to seeing old friends and new at Health 2.0 in Boston.  

While we're on the subject of conferences, I'll mention just one more: I'll be speaking at Medicine 2.0 in Boston this fall, and HealthCamp Boston will take place the day before: September 14.  Please hold the date for HealthCamp -- whether or not you'll be attending Medicine 2.0 -- and let me know if you'd like to help organize (or sponsor) this unconference.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


May 06, 2012

Nothing About Me Without Me - Participatory Medicine, Meaningful Use, and the American Hospital Association

Meaningful Use Stage 2 regulations were released in March by CMS and ONC.  Over the past month or so, I've been working with other members of the Society for Participatory Medicine (thank you, all) to prepare comments on these regulations from the patient perspective.  Last Friday, we filed two comment letters on the proposed regulations. One letter to the ONC on Meaningful Use Stage 2, and one letter to CMS on Meaningful Use Stage 2. Each letter opens like this:

The Society for Participatory Medicine applauds the work done to date in focusing on patient engagement in the proposed Stage 2 Meaningful Use regulations and the proposed Health IT Standards regulations.  It is our hope that the final requirements will be even stronger and more focused in this regard than the current drafts. As set forth in greater detail in the attached letter, we have a number of comments that we believe will improve the regulations and their use as a lever to improve patient experience, patient engagement, patient care and, ultimately, patient outcomes. We would like to highlight two in particular:

  • We favor improving the likelihood that patients will access their data by allowing for some automation of the process of accessing and downloading patient data, using existing technologies that protect patient privacy and security.
  • We also favor immediate patient access to information in the patient’s electronic health record – unless the patient has elected otherwise.

The overarching principle with respect to patient access to electronic health record data running through the entire meaningful use regulation and the health IT standards regulation should be:

    “Nothing about me without me.”

The Society for Participatory Medicine has individual and institutional members nationwide and has a governing board comprised of both clinicians and patients. It was founded to study and promote participatory medicine, which we define as being centered on networked patients shifting from being mere passengers to responsible drivers of their health, and providers who encourage and value them as full partners. For further background on the Society and its activities, we invite you to see the Society’s website (, its online journal, The Journal of Participatory Medicine ( and its blog,

Comments are being accepted through Monday May 7, 2012.

I invite you to read the Society for Participatory Medicine press release, Participatory Medicine Society Urges Quick Patient Access to Medical Information, outlining the Society's stance on the issue, and the recent posts on the Society's blog,, explicating the SPM Meaningful Use Stage 2 comment letters a little further, and putting them in context -- in particular, juxtaposing them against the American Hospital Association comments calling for a 30-day delay in patient access to information once it's in their EHRs.  (The proposed rule calls for up to 36-hour and 4-business-day delays, depending on context, and the SPM comments call for immediate access.)  Technologically literate commentators, including Fred Trotter, take issue with the AHA's view that 30 days are needed to respond to a request for an EHR.  (Fred's post says a lot more -- check it out.)  

Finally, take a few moments to consider Regina Holliday's comments on the proposed rules, filed in the form of a slideshow featuring her paintings:

Long Stories: The Story Of Meaningful Use and Why the patient voice matters..

May 02, 2012

Monetization or medicine? Tracking organ donor status on Facebook

MP900402858Facebook has announced a new box you can check off on your profile: organ donor. (It's available in the US & UK so far, for a total of almost 200 million members; more countries in the works.)

What does this mean and why should you care?

At bottom, this means that Facebook is adding yet another data point to the myriad bits and bytes it already has on so many of us (What's your birth date? Have you ever broken a bone? etc.), which it slices and dices in order to target ads and sell to third parties (and flog news of its upcoming IPO). Checking off the organ donor box on Facebook doesn't make you an organ donor (you need to register with your state DMV), but serving up easy links to organ donation registration sites and motivating registration by showing that friends have registered (or at least checked the box) -- i.e., "norming," in the parlance of BJ Fogg, as quoted in the NY Times piece linked to above -- is likely to increase donor registration, and to increase family awareness of the choice at (or, preferably, before) the time when family members are called upon to carry out the wishes of a donor.

If you are spooked by the idea of Facebook having this information about you, I would ask whether you make your birth date visible on Facebook. I don't; revealing birth date makes identity theft that much easier, and I'm more spooked by that possibility than by the prospect of everyone on Facebook knowing my organ donor status.  I am not concerned (as some are) about someone making the decision to treat me as nothing more than a vessel for donated organs, and I think that it should be possible to strike a balance between a good death and preserving organs for transplant. 

Anything we can do to legitimately increase the supply of organs for donation is a good thing -- too many people languish and die while waiting for an organ.  My problem with this solution is that it is as much about Facebook as it is about organ donation.  While I would expect donor numbers to go up as a result of this initiative, the numbers are not likely to be too significant, because implementing the choice to donate organs requires doing more than clicking something on Facebook -- it requires going through all the steps necessary to memorialize an organ donation in the real world.

I would like to see Facebook using its muscle to lobby for a presumed consent law -- meaning that in the absence of formal directives to the contrary, the presumption should be that a person has consented to organ donation at the appropriate time, reversing the presumption now in effect in this country.  The company has taken an interesting first step, and it will be interesting to see if it pursues this issue beyond the limits of its own pages and monetization strategy.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting