The Future of Health IT

An important aspect of President Obama’s health plan (partly funded through this year’s stimulus package) is health technology.  As noted in a prior blog post, section 4101 of the ARRA provides qualifying health providers with Medicare reimbursement incentives for implementing Health IT that meets the statutory criteria set out in that section: meaningful use, participation in a health data exchange, and clinical outcomes reporting.  By setting standards and providing incentives, the federal health policy will have a substantial impact on health care technology over the next five years, as billions of dollars are poured into health IT investment.

The question presented here is where will all of this public and private investment lead Health IT in the next few years?

Data Exchange And Availability

One of the areas of major emphasis in the ARRA is the ability of health care providers to more easily share information with other providers, patients, and others who have a legal right to receive such data.  In particular, emphasis has been placed on the ability to transmit data to health exchanges, and to be able to produce data for the Feds on health outcomes (such as reporting hemoglobin a1c’s values over time to evaluate if a diabetic patient is responding positively to the care provided).  Health data exchanges today are on the rise, according to ihealthbeat.org, up to 57 operational exchanges from 42 the year prior.  These health exchanges are being used to exchange data between individual providers in an effort to improve care coordination and to improve care quality.

More specifically, for patients with several doctors who may specialize in a variety of treatments or health conditions, health exchanges have the potential to ensure that lab data ordered by one physician is made available in a secure and reliable manner to all the physicians involved in providing health care.  Health exchanges also can ensure that a patient’s medical history (particularly their prescription history) is available in a consistent format to all care providers, saving time at each visit and reducing risks to patients that might forget a prescription or past medical procedure.  Sharing lab results also has the potential to reduce costs and patient injury by reducing the number of duplicative tests ordered for the same patient by different providers.  This is a common problem for patients with a coordinating care provider who end up in the hospital and the attending physician is stuck ordering duplicate tests.

Looking into the future, I would expect that health data exchanges (HDE) would become more prevalent so long as the total cost to implement and maintain the HDE are less than the costs saved/avoided by the data available in the HDE.  One of the other factors that will impact the growth of HDEs is the number of peer-reviewed studies of their efficacy.  Today, there is relatively little information on this topic because most HDEs are new or still under development, but in the next few years more definitive information should be available for analysis and review by eager technologists and researchers.

One of the great challenges for the HDE movement is maintaining patient privacy.  HIPAA was originally implemented in part to specifically address patient privacy, as have a number of other state laws on this topic (for example, the Maryland Medical Records Act, See Md. Health-Gen. Code Ann. § 4-301 et seq.).  And other states are getting in on the action to protect consumer privacy, including Massachusetts, Minnesota, and Nevada, just to name a few.

However, laws alone may not be enough to effectively regulate and protect the availability of health data.  In the present HIPAA enforcement regulations (which were modified by ARRA this year), the top fines (where the act in violation of the security regulations was a negligent rather than an intentional one) are relatively low compared to the potential size of an HDE (for example, if a company like google or Microsoft was to become a dominant HDE) because the fines are a flat rate per incident rather than being scaled according to the company’s gross revenue or the severity of the breach or finding.  The ARRA did move in the right direction this year by implementing a four-tiered approach to violations from the original enforcement authority under HIPAA, but further scaling may be required for this to become an effective deterrent to lax security practices.

Furthermore, having a patchwork of privacy laws increases the overall cost of compliance for HDEs, which increases the cost to implement these systems without necessarily improving the actual security of the information stored at the HDE.  This is caused by regulatory requirements of overlapping but also potentially conflicting laws, along with the need to respond to multiple authorities with the right to audit or investigate the HDE (as larger HDEs will undoubtedly operate across state lines).  Sadly, I imagine that this problem will probably get worse before it gets better, given the number of relatively autonomous sovereign powers within our country (5o states + the federal government) and the scope and scale of the privacy issue being considered.

Attitudes Towards Privacy

Our future privacy policies may also be impacted by the attitude of our youth to privacy today.  Social networking sites, for example, allow for the exposure of a lot of information about the youngest among us, but the predominant users of these systems don’t seem to mind very much.  Now, of course, facebook is not known for the health data available on its users, so who knows whether college kids would be posting their latest hemoglobin values as readily as they do about the parties they were attending and pictures snapped of them by the college paparazzi, but it stands to reason that the next generation’s attitudes towards privacy will be substantially different than the present one that has been called to govern the nation.

The result may be a reduction in the concern about privacy with an increasing criminal penalty for those that engage in theft of information.  For example, perhaps instead of worrying as much about whether health data is squirreled away in an underground bunker with Dick Cheney, the future leaders of the nation will make this data generally available via the internet, ultimately reducing its value to would-be thieves.  For myself, I can’t say it matters much if others know than I have high cholesterol and a family history of diabetes, but I also don’t think there is much stigma attached to either of these conditions as there might have once been (or might still be for other health issues).

Data Quality and Trusted Sources

HDEs will also need to address head on the quality and reliability of data stored in their databases.  Today, data systems do not generally go beyond the initial setup of some kind of private network and the file formats that are acceptable for data to be exchanged.  Inherently, one system trusts the data it receives from the other and merely re-publishes it into its own database, identifying the source of the data.  Usernames and passwords may just not be enough for everyone to know that the data being sent or received is accurate and reliable.

In addition, even though HIPAA (and some other laws) have placed a small emphasis on technical encryption, the truth is that little has really been done with these technologies for most systems today to ensure that data entered is not repudiated later by the person that purportedly entered it.  For example, many commercially available database systems are not natively encrypted.  Local area network activity on the wire is rarely encrypted, again relying on the border security devices to keep outsiders out of LAN activity.  Passwords are not consistently complex across an enterprise (especially where multiple database systems maintain their own passwords and accounts), and certainly cannot reasonably be changed frequently enough to ensure the password has not been compromised (without the user community revolting against the IT staff).  And users routinely share passwords even though there is a federal law against it and in spite of the numerous repeated messages from system administrators to not share passwords.

Furthermore, data exchanged between systems relies on the initial configuration of the networking that connects the two systems to remain uncompromised.  There is no further system verification to ensure that messages actually received across these systems are correct in the typical data exchange design.  TCP itself was designed with a checksum in each packet, but that only tells the receiver if the packet received matches what was intended to be sent, not whether the data sent is coming from the human/system source alleged (e.g., the laboratory technician or physician that actually created the entry in the first place).

I anticipate that the future of authentication will be to move towards far more sophisticated and multi-level authentication (even though the biometric movement seemed to have lost steam, at least in the general consumer market).  For example, instead of or in addition to a username/password, systems may also generally implement a token, or other physical card to grant access (such systems exist and are in general use today for some systems).  Other security measures may involve thumbprints or biometrics.  I would also imagine that more sophisticated encryption algorithms could be used beyond 128-bit cipher, and that encryption might occur at a more basic level than it does today (if transmissions are encrypted at all).  For example, databases themselves may be encrypted at a record or table level, or application access could be managed through an encrypted socket instead of plain text as many operate now.

Beyond user access to put in data, surely there be could some additional layer of verification that could occur once data has been received from a producer system which could be, by design, independently verified before being committed to the receiving system.  The alteration (or just erroneous entry) of data in transport from one system to another creates the real possibility of a bad health care decision by professionals using the data.  This is certainly one of the major weaknesses of consumer level HDEs such as those from google or Microsoft which must rely on the consumer to enter their own lab and pharmaceutical information into the database when that data is not available electronically, or on data providers that rely on administrative or clerical staff to actually do the data entry without further review before distribution.

HDE Information Security

Today, a number of technologies exist that allow for data backup and redundancy to ensure that systems can be highly available and resistant to significant environmental or system disasters.  One category of technology is called “cloud computing,” which is a kind of modern equivalent to what application service providers (ASP) of the 1990’s were offering, or what the ancient mainframes of yesteryear offered to computing users back in the bad old days of the 1970’s.  What is fundamentally different today, however, is the possibility of having massively redundant and distributed information systems that belong to a cloud, where both ASPs and mainframe computing was often centralized into one server room or series of server rooms in one facility.

A common example of computing in the cloud today is gmail, which is an email service provided by google for free to consumers.  There are still, somewhere, servers connected to the internet and controlled by google that will respond to SMTP requests, but google most likely has these servers distributed all over the planet and connected to a larger, redundant network infrastructure.  Data stored on these servers are likely real-time replicated so that all gmail replication partners are up to date, regardless of which one you actually connect to when you use your web browser to navigate to your email account.  Gmail has been around for some time now, and there are a fair number of users (26 million according to one article as of last September; wikipedia claims there are 146 million gmail users each month as of July 2009).  Perhaps Health IT will be the next internet “killer app.”

And looking down the road, the future of Health IT likely involves some kind of “cloud computing” model where health data is not stored locally on an organization’s server.  This model will provide for additional flexibility with data transfer, improved system redundancy, and higher availability than is typically possible in a single enterprise or within a single server room.

Cloud computing, however, does pose other security and privacy concerns.  (See this article on CNET that addresses some of these same concerns)  For example, will staff of the cloud computing service have some kind of access to the actual data entered into the system?  Will these systems have a way of keeping those administrators from changing or accessing data (for example, by encrypting the data to place it out of reach of administrators)?  Who is liable for loss of the data?  Will the HDE seek to (and will courts and lawmakers allow it to) unreasonably limit liability for unauthorized access?  Will the HDE be indemnified by a government agency?  Will the HDE pay for itself by allowing advertisers access to data stored by the HDE?  Will it utilize a more democratic approach (for example, as facebook has recently been employing to ratify adoption of changes to policies in place that affect its user community)?

Stay tuned.

Health IT Implementation – an Overview

Health IT has been put back into the forefront of the Obama national health care initiative, in part because of Medicare incentives built into the ARRA for health care providers that implement and meaningfully use a health technology system in the next few years.  The cost savings is premised in part on the success of the installation and implementation of the information system to be used by health care providers.  This article will focus on some of the details of implementing an electronic health records system, along with some of the pitfalls that can keep a project from being completed successfully.

The End Goal is Meaningful Use

In order to receive reimbursement from the Medicare program, the ARRA requires that a provider demonstrate meaningful use of the system, connection to a health data exchange, and submission of data of clinical quality measures for patients at the practice.  (See earlier post on this issue)  Reaching these goals goes beyond the mere technical installation of some computer system; “meaningful use” in particular will likely require health care providers to show that the actually use the computer system in managing patient care, reducing errors, and improving health outcomes for individual patients.  Getting there requires effective planning for the project and a productive implementation process.

The good news for providers who want to implement an EHR is that: (a) the data a provider needs to effectively see patients will be available when you need it (no more “lost chart syndrome”), (b) the chart documentation will support the diagnosis and E&M codes billed to the insurer, (c) EHRs can be tightly integrated with a practice management system to reduce data entry errors and improve billing, (d) most EHRs will make clinical or mandated reporting easier as compared to paper charts, (e) lab results can be electronically imported into the EHR from major lab providers, (f) improved E&M coding can lead to better reimbursement, and (g) an EHR investment can be viewed by your staff as an investment in them, leading to higher staff retention rates and satisfaction.  But there is a cost to achieving these benefits. 

For one, some of the office workflows for handling patient care may need to be modified or adjusted to incorporate the EHR.  Some workflows that operate on paper in an office will not convert efficiently to a computer system.  Forms used to process or document patient care may also need to be modified when they are converted into the EHR.  EHR installations for health care providers tend to expose workflow problems and breakdowns that require attention in implementation for the project to be successful.

Secondly, all the staff in the office will need to be computer literate, and generally, physicians and other health care providers will need to be able to use a computer effectively while examining their patients.  This has become less of an issue as more doctors and other providers are trained to use a variety of computer systems at medical school, but computer literacy is still a major issue for some practices in the nation.

Third, EHR projects are high risk – there is a substantial chance that the project will be derailed for any number of reasons, including a lack of a process for effectively making key decisions, office politics, the capital expense to acquire computer hardware and software, and a lack of technical expertise among the implementation team, among other challenges.  These can be overcome or at least mitigated by sufficient advanced planning by the organization.

And finally, most studies of EHR installations suggest that your practice will be in the minority of practices using an EHR (though there has been an improvement in the market penetration here over the last few years).  This is partly because of the expense of implementing the systems, and the longer-term costs of maintaining them.

You can get there if you have a good plan.

Manage Expectations Early and Often

No, an EHR will not solve your workflow problems without your help.  An EHR is not free, even if licensed under an open source software license.  The data that is collected in the EHR is useful, but will require further technical assistance to be useful for research or analysis.  Staff can’t keep doing things the same way and expect a different outcome (besides this being one definition of insanity, EHRs are not magical beasts with wings, and magical thinking does not lead to a happy end user).  Doctors won’t be able to see 50 patients per day after install if they were only able to manage 20 per day before.  A project that lacks goals that are attainable will fail.

Any system project can be a victim of unreasonable or unrealistic expectations.  Those leading the project need to be frank about what can be achieved and at what cost to the staff using the EHR.  Expectations can be managed by establishing tangible goals and having a workable project plan with real milestones and a clear assessment of the resources (financial and staff time) that will be needed to reach each one.  For example, implementing the EHR two months from purchasing it can be realistic, but only if the provider’s office is prepared to commit significant time to the planning and installation, particularly in identifying forms that need to be developed electronically and lab interfaces that need to be installed (two of the most time-expensive portions of an EHR implementation).  The need for effective training can also not be understated – staff should not expect they can pick up use of the system in an hour or two, or learn as they go with live patients in the room.

Picking an Information System

Finding the right EHR is an important task and should not be left to chance.  There are a lot of EHR vendors in the market place today with a variety of installations, history, and effectiveness.  Developing a written request for proposal and requiring an objective process for evaluating responses to the RFP is essential to fairly evaluate the vendors in the market place.  Sending the RFP out to 100 vendors is also not helpful, nor is having a 100 page requirements section.  But your prospective partner for this project should be able to effectively respond to your RFP and explain in satisfactory detail what the options and costs are for implementing the proposed system.

Furthermore, your organization should form a search committee that is comprised of enough staff to provide meaningful input on the responses to the RFP, and to interview qualified vendors to assess for the needs of the essential practice areas.  Vendors should also be able to competently demonstrate their project to the committee’s satisfaction, so that the committee can identify the best two candidates for the job.

To help encourage staff buy-in (where your facility is sufficiently large that the search committee may not represent all interests), I have also recommended that the finalists demonstrate their product to all staff, and to put the final decision to a group vote.  This doesn’t work in all organizations, but the more effort you put into including the staff that use the system in the process, the more buy-in to the project you will garner, which increases the odds of a successful implementation.

Vendor Negotiations

Once you have identified the best candidate EHR, your organization should begin to examine the terms of the contract with the EHR vendor.  Most vendors have a standard form contract that describes the terms of the relationship, particularly for ongoing support and updates to the product.  These contracts are complicated and an attorney can be helpful to ensure that the contract fairly represents the relationship, costs, and promises made by the vendor along the way.

Negotiations can take some time to complete, particularly where multiple parties are involved or there are substantial costs involved.  Hammering out contract details with the vendor is an important step in the planning process.

Major Milestones

Once a vendor has been chosen, most EHR implementation project plans will have the following major milestones to get to a successful go live: (a) form a planning committee, (b) form a technical team, (c) review and make decisions on the requirements for the project, (d) install the server, software, and workstation software, (e) develop all required clinical content (such as electronic forms, flowsheets, and data requirements) for go live, (f) implement all interfaces for data flowing in and out of the EHR, (g) conversion of all charts from paper into the EHR, (h) staff training completed, and (i) go live with the system.

The planning committee should include the clinical departments that will be using the system, and should be designed to regularly meet up to and through the go live date.  The committee should be charged with enough authority to make decisions about the project’s implementation, and should become your initial group of “super-users” or staff with more training about the EHR.  Your super users should then become sources of information for the rest of the staff as they work through integrating the EHR into their practice.

The technical team is comprised of the IT staff that are responsible for installing the server and workstation equipment, getting the EHR software and database installed properly, configuring interfaces between systems, and installing any supporting network or peripheral technology.  This team should regularly report to the planning committee or the project manager for the installation.

The planning committee is responsible for making the decisions about how the EHR will be implemented.  The vendor supplying the system should regularly participate in the committee’s meetings, and generally the project manager should chair the committee.  Actions and decisions of this committee should be documented and distributed to the members.  In my experience, the meetings of the committee or geared toward training the members on the details of the EHR so that they can determine how the system should work for their departments.  These meetings can be contentious as a number of people will need to agree, but in the longer term, this process helps to make sure that the project is implemented appropriately.

This committee also should be responsible for identifying project priorities.  The reality is that no EHR implementation can go live with every request ready – there are always too many requests and not enough time to implement all of them.  This committee should be prepared to identify what’s most critical and clarify these priorities to the staff involved in the installation.

In addition, this committee should be committed to be thorough and address concerns along the way with specific implementation decisions and priorities.  Some decisions made early on can be very time consuming and costly to correct later.

The “clinical content” of the application includes the electronic forms that will be used to document care, the organization of the sections of the EHR that display structured data (such as lab results for a patient), and other functional areas of the EHR that are susceptible to modification at implementation.  This development may be handled by the vendor.  However, post-go live may require the provider to maintain the content developed during implementation, or be in a position to add new content.  In some cases, third parties may be able to sell premade clinical content separately from the EHR vendor.  All of this customization of the product requires special attention to ensure that the content developed meets user requirements and that the content is developed according to standards acceptable to standard practice.

Most EHRs support some interfacing with other products, using a common language like HL7.  If interfaces with other software or third parties is essential to the implementation, substantial lead time and attention to detail is required for these interfaces to be ready at the go live date for the project.

Some meaningful portion of the existing paper charts will need to be converted to electronic format into the EHR, prior to go live if at all possible.  This is a very time-intensive process, and is often used as a training opportunity for users, who can be scheduled to convert specific charts as part of learning how to use the EHR.  However, most practices have many more charts than users available to convert them, and many project planners will budget additional resources to aid in the paper conversion process.

Some practices opt to extract specific data from a paper chart into electronic format, using specialized clinical content for this purpose.  Other practices may simply scan and index the paper chart documents as is into an electronic document and attach it to the chart as the chart history.  Still others will do a hybrid of these two solutions.

Training is also a very important aspect of any EHR implementation.  From my experience, up to 20 hours of training may be required for super users of the EHR; the minimum is about 4 hours for sufficient exposure to the basics of an EHR.  Depending on the total staff to be trained, scheduling training classes for an organization may be a substantial time committment.  Generally the EHR vendor can give guidelines on the minimums for training to gain proficiency on the system.  Note that no implementation’s training will end at go live; generally post go-live training and ongoing training for new staff after the system is implemented are ongoing expenses of the EHR.