Tag Archives: ITAC Health

Regulating HIT Software in Canada and the US

I have been following the debate regarding Health Canada regulation of HIT software (including physician EMR software) and have written several blog posts on this topic.  While the Canadian debate seems to have taken place after the regulations were put in place and decisions made to actively enforce them, the US debate is taking place BEFORE decisions regarding how best to regulate health IT for patient safety are made.

As it does for many issues facing the health IT industry, HIMSS is seeking input from the community on how best “to foster a large scale dialogue on the issue”.   In a recent blog post (HIMSS actively engages its members and the broader community through blogs and other social media), HIMSS summarizes the current situation in the US and poses the question “What should be the role of the federal government in ensuring the patient safety of health IT products and the settings in which they are utilized?”

Do we need a similar debate in Canada or is the matter already decided?  I fear that much of the debate in Canada is taking place behind closed doors and that there is little opportunity for input from the broader stakeholder community.


Health Canada Medical Device Certification – Differing Views?

Just under two weeks agoI attended and blogged about a workshop on the Health Canada medical device regulations hosted by ITAC Health, MEDEC, and COACH. This workshop explored the applicability of these regulations to health IT software. Since that workshop I have learned that various stakeholders have different views on the extent to which the Health Canada regulations should apply to health IT software.

The HIT vendor community appears to support application of the Health Canada regulations to HIT software. On 7 September 2010 ITAC Health published a blog post summarizing their position on the Health Canada regulations.  This post states that “ITAC Health supports the application of Health Canada’s Medical Device Regulations (MDR) as they apply to patient management software defined in Health Canada’s Notice dated May 21, 2010.  This regulation is appropriate for patient management software products that manipulate and interpret clinical data, which require a high standard of quality.”

According to a comment posted by Brenda Seaton on the “Canadian EHR Professionals” LinkedIn group discussion forum, healthcare CIOs “have pushed back because of the very legitimate operational challenges, of which legacy systems are one“.    Based on what I am hearing from other sources,  these concerns are causing Health Canada to reconsider their definition of patient management software.

So, it appears that the community is divided on the application of the Health Canada regulations, with the vendors lining up in support of the regulations and the health IT user community working behind the scenes to lobby for additional changes to the regulations.  There is little public information available regarding these discussions and the views of the various stakeholders.  Does anyone have any additional insight that they can share?


HIT Adoption as a Performance Indicator

The OHA Board recently identified the strategic performance indicators for its new 2010-2013 strategic plan.  Of particular note, “Health Information Technology Adoption” was selected as one of the performance indicators.  The complete list of indicators includes:

  • Number of Alternate Level of Care (ALC) Patients
  • Patient Satisfaction
  • Staff Engagement
  • Patient Safety Composite
  • Adoption of Governance Leading Practices
  • Wait Times Composite
  • Health Information Technology Adoption
  • Cost per Capita

According to the OHA, the next steps with respect to use of these indicators include “a review of the eight indicators by selected industry experts and development of definitions, baselines and targets”.   I do hope that the Health IT industry has a role to plan in refining the indicator related to Health Information Technology Adoption.  ITAC Health, do you have a position on this matter?


Greg Reed Unplugged

Greg Reed, the new eHealth Ontario CEO, made what was arguably his public debut today at an ITAC Health sponsored information session.  The sold out event was attended by 250 people, many of whom were vendors.  Speaking without the aid of Powerpoint slides, Mr. Reed spoke briefly about what he has learned over his first 2+ weeks on the job and then fielded questions for the better part of 90 minutes.  During his opening remarks. Mr. Reed offered the following observations:

  • Observations on the Ontario health sector:
    • He is impressed by the  innovation and activity in the at the regional and local level.
    • He wonders how best eHealth Ontario can best create environment for success and even accelerate progress and welcomes input in this regard.
  • Observations on eHealth Ontario
    • Note that eHealth Ontario is a challenging organization given the events of the past year.
    • The events of the past year have created tremendous turmoil among eHealth Ontario employees and there is a need to instill stability in the organization.
    • He is moving quickly to put in place a senior team.  As noted in previous blog posts, three new Senior Vice Presidents have been appointed. Two of these positions have been staffed with new people to the organization.
    • He is working to remove obstacles to progress.
  • Observations on eHealth Ontario’s role.
    • Mr. Reed noted that it is too early yet to talk about strategy.
    • Believes that eHealth is fundamentally about making sure that all providers have up to date information about the patients that they serve and the tools to effectively use this information.
    • Feels that we need to think about the patient first and that we need to more clearly define what is meant by “patient centred care”.
    • Asked several times “Who is the advocate for the patient?”
    • Wondered who is “painting a picture of what success will look like?” and mused whether doing so is an appropriate role for eHealth Ontario.
    • Identified four possible roles for eHealth Ontario that he wants to explore with various stakeholders:
      1. Prime contractor that coordinates the efforts of various parties for projects that span multiple organizations.
      2. “Fill the white space” not addressed by the various stakeholders across the complex healthcare ecosystem.
      3. Drive standards and interoperability, facilitating consensus and serving as arbiter when consensus cannot be achieved.
      4. Acts the overall architect and defines the long term strategy for electronic health care in Ontario.

Mr. Reed concluded his opening remarks by sharing his views on leadership.  He stated that effective leader can “accomplish anything if you give credit to everyone else” and emphasized the need to work in a collegial, cooperative manner to reach consensus.

Following these opening remarks Mr. Reed opened the floor to questions.  Mr. Reed’s responses to these questions included the following comments:

  • eHealth Ontario has no credibility.  The organization will only gain credibility by doing, not talking.
  • Stated that he was committed to an open procurement process and that vendors do not need to fear retribution for speaking out.
  • He is undecided regarding the need for national standards.  Stated that he is still getting differing opinions and he is still trying to assess these opinions.
  • Feels that the currently articulated eHealth Ontario strategy has many good elements but he is not sure that it is a comprehensive strategy.
  • He is impressed by the various initiatives taking place with little or no assistance from eHealth Ontario and wants to understand how eHealth Ontario can accelerate progress.
  • Feels that having an electronic health record for every Ontarian by 2015 is still a laudable goal but thinks that there are things that eHealth Ontario can do along the way that are unrelated to this goal but that deliver tangible benefits.
  • Believes strongly that decisions should not be made on the basis of who is right but on the basis of what is right.
  • Believes that starting with the patient perspective helps to clarify discussions and that eHealth Ontario can set the tone in this regard by focusing on the patient and assessing the facts.
  • Getting alignment is a big, messy process.
  • Suggests that one role that eHealth Ontario can play is to keep asking questions that keep people focused such as “What is in it for the patient?”
  • Noted that eHealth Ontario is in the penalty box at the moment and that it will take time and tangible results to restore trust and credibility among all stakeholders.
  • Would like to do a post mortem on the diabetes registry procurement process to determine what worked and what did not.  Feels that the current procurement process is prolonged and expensive.
  • Feels that the public is not ready yet to hear about eHealth success stories and that eHealth needs to regain credibility first before they will be willing to listen.

I was impressed by Mr. Reed’s performance today.  He thinks quickly on his feet, is willing to answer difficult questions, and is not afraid to admit what he doesn’t know.  In addition, Mr. Reed has quiet sense of humour that he uses very effectively at the appropriate times.

Mr. Reed seems sincere about wanting to engage with all stakeholder communities and to facilitate collaboration among these communities.  He clearly has a tough road ahead of him but seems up to the challenge.


Public eHealth Education

I am currently listening to a webcast of the Strategic Planning Working Group of the U.S. Health IT Policy Committee.   They are discussing feedback from various stakeholders received through various open processes (wish we had such open processes in Canada) including a listening session and a blog. The Working Group is identifying key themes gathered through the open comment process and is formulating a set of recommended changes to the draft U.S. healthcare IT strategic plan.  This transparent process makes it clear how input from various stakeholders (including the public) is addressed and impacts the strategic plan.

One of themes discussed during the working group meeting was the need to educate the public on the benefits of healthcare IT.  I have seen this same theme raised on several blogs and during a couple of meetings in which I have participated over the past few weeks.  A consensus seems to be forming that more work is required to raise awareness and visibility of healthcare IT and the role that it plays in the delivery of care and management of the health system.  This need is particularly acute, IMHO, in Canada, where eHealth is in danger of becoming a dirty word.

Do you feel that we need to spend time and effort educating the public about healthcareIT?  If so, which organizations are best positioned to take on this tasks?  Personally, I’d like to see both COACH, the Canada’s health informatics association, and ITAC Health, Canada’s heatlhcare IT vendor’s association, take active roles.  While they might not be the most appropriate organizations to lead such an initiative given their obvious biases, I believe that they have important perspectives and knowledge that is not possessed by any other group.

I have heard that Infoway is going to launch a public awareness campaign.  I do hope that that this campaign takes advantage of many different channels including social media. I also hope that they co-opt the insight and talents of many partners including but not limited to COACH and ITAC Health.  I say “hope” because very little information on Infoway’s plans has been released (an unfortunately typical situation where Infoway is involved).


eHealth – Canadian economic driver?

I have posted on several occasions about the seeming lack of national  industrial development strategy for the Canadian eHealth industry.   Hence,  I was pleased to read about a healthcare vendor taking on this cause, a vendor that has been very successful in the Canadian market.  Where is this vendor based?  Toronto?  Ottawa?  Vancouver?  Nope, Auckland, New Zealand!

Ian McCrae, CEO of New Zealand-based Orion Health, is quoted in a New Zealand Herald article


as saying “We have a chance of being a hotbed of health innovation.  It’s something we should actually take advantage of because there some things we can’t do.  We can’t build cars, we can’t build spaceships, there’s lots we can’t do.  But this is one thing we can absolutely world class at.”  Hmmm … seems that we could say the same thing about Canada.  Canadian healthcare IT vendors, what do you think?  What is ITAC Health’s position on this matter? Orion has clearly demonstrated how success in the “home” market can be leverage for success in global markets.


eHealth as an economic driver?

eHealth week 2010 is in full swing in Barcelona, Spain this week.  As with other conferences taking place over the past few months, I have been following this conference through Twitter, blog posts, and online media sites.  I was interested to hear that Zoran Stancic, Deputy Director General of the European Commission’s Directorate General Information Society and Media (DG INFSO) believes that “eHealth offers not only the possibility to increase efficiency and quality care, it can also be seen as a growth machine for Europe”:


I have long argued that Canada is not doing enough to leverage its eHealth investments to drive economic development.  Much of Canada’s installed healthcare IT infrastructure in hospitals and regional health authorities is based on software from multinational and U.S. based companies.  While some of these vendors do employ Canadians and the Ontario government made a significant investment in an Agfa R&D facility in the Kitchener-Waterloo area, there is no comprehensive and integrated national strategy for positioning Canada and Canadian organizations as world leaders in what is arguably one of the fastest growing IT segments.

What do you think?  Should Canada take a more proactive position on developing Canadian eHealth solutions for our own use and for export? Can we “kill two birds with one stone” and use eHealth to address both the sustainability of our health system and create new, high value jobs?   If so, which organizations (both inside and outside government) are best position to play an active role in promoting and implementing this agenda?