This alone will not be enough to achieve the widespread interoperability and electronic exchange of information necessary for delivery reform where information will routinely follow the patient regardless of wheter they receive care....

The overarching goal is to develop and implement a set of policies that would encourage providers to routinely exchange health information through interoperable systems in support of care coordination across health care settings.  

HHS therefore seeks comment on several options for encouraging HIE among providers and settings of care through a hodge-podge of existing statutory vehicles (primarily CMS and ONC programs and projects). In addition to requesting comment on these existing vehicles, CMS and ONC seek to identify what is currently working to encourage HIE, and which changes would have the biggest impact on HIE adoption, including regulatory requirements.

Furthermore, although long neglected under the EHR Incentive Programs, CMS and ONC specifically seek comment on what policies and programs would have the most impact on post-acute and LTC care providers as well as behavioral health.  They ask for insight into how these programs and policies should be implemented and developed to maximize care coordination and quality improvement for these populations. In addition, CMS and ONC specifically seek comment on policies and programs which would most impact patient access and use of their electronic health information for management of their care.   

Post-Acute and Long-Term Care Providers.  HHS acknowledges the low rates of EHRs and HIE among LTC and post-acute care providers and identifies existing authority which could be leveraged to expand HIE.  These include incorporating HIE as key components of:

1. Medicaid health homes;
2. Demonstration and pilot projects under Medicaid and the Childrens Health Insurance Program (CHIP);
3. Home and community based services (HCBS), which would include LTC;
4. State expansions of HIE infrastructure as part of the Medicaid EHR Incentive Program, and
5. CMS Conditions of Participation or Coverage

Settings of Care.  HHS additionally acknowledges the need to accelerate HIE across providers, including ambulatory care, behavioral health, laboratory, and post-acute and LTC. For example, HHS seeks comment on:

1. New e-specified measures for exchanging summary records following transitions of care aligned with CMS quality reporting programs, including the EHR Incentive Programs;
2. Medicare Shared Savings Program, requiring or encouraging Accountable Care Organization (ACO) to engage in HIE as part of coordination of care;
3. Payment and service delivery model testing under the Affordable Care Act, such as demonstration of use of interoperable technology for HIE to facilitate model participation decisions and requirements;
4. Model testing to align Medicare and Medicaid financing and care integration under the Capitated Financial Alignment model.

Consumer and Patient Engagement.  HHS and CMS seek to encourage engagement of patients in their care by improving their access to health information and electronic communication between their health care providers.  Options to encourage consumer and patient engagement include:

1. Incorporating new measures into Medicare Advantage Program consumer assessment serveys (CAHPS);
2. Blue Button availability to all CMS beneficiaries;
3. Payment and service delivery model testing under the Affordable Care Act, such as demonstration of incentives for consumers to more actively participate in their health; and
4. Direct access to lab results from laboratories (CLIA and HIPAA Amendments).

The RFI will be published today in the Federal Register.  Comments may be submitted up to 5pm on April 22, 2013. 

This year, ONC is kicking off several activities to support HIE governance. First, a federal funding opportunity is available for existing governance entities to further develop and adopt policies, interoperability requirements, and business practice criteria relating to HIE. Applications may be submitted until February 4 on Grants.gov. 

Secondly, Dr. Mostashari and ONC have scheduled an open Town Hall listening session for this coming Thursday, January 17, as well as February 14 in order for stakeholders to express their priorities, concerns or issues.  Based on stakeholder input, the HIT Policy Committee and HIT Standards Committee are expected to hold a public hearing then on January 29 to discuss current HIE policies, practices and impediments, as well as opportunities to strengthen and improve governance. 

Finally, ONC will develop and publish a series of governance "guidelines" based on the feedback it has received for effective and trustworthy HIE.  Stay tuned for more information on ONC's new site for HIE Governance. 

Mobile medical apps designed for use on phones and tablets are generally unregulated. In July 2011, the FDA published guidance indicating its intention to use the existing regulatory framework for a small subset of apps. It planned to scrutinize apps used as accessories to already-regulated medical devices and apps that use attachments to turn mobile devices into regulated medical devices.

Even as the FDA finalizes its guidelines, President Obama has signed the “Food and Drug Administration Safety and Innovation Act” which includes a provision laying the groundwork for broader regulation of mobile medical apps. Section 618 gives the HHS Secretary until January 2014 to issue a report with a proposed strategy for a risk-based regulatory framework for HIT, including mobile medical apps. The new law requires that the framework promote innovation, protect patient safety and avoid regulatory duplication.

In developing the framework, the Secretary has the option of assembling a working group of stakeholders to provide guidance. If the Secretary does form the group, it is required to have representatives from a variety of groups including patients, providers, health plans, startup companies, venture capitalists, technology vendors and small businesses.

This puts mobile medical app developers in a difficult position.

The FDA is still finalizing a narrow set of guidelines. But in 18 months the Secretary’s report will likely open the door to broader regulations sometime in the future. For now app developers are stuck with the reality that at an unknown point in the future there will probably be more regulations of an unpredictable nature.

Christopher is a former software developer and current J.D. candidate at the Earle Mack School of Law of Drexel University.  He is working with the Attorneys at Oscislawski LLC as a summer intern.

Entitled "The Landscape and a Path Forward," the HIE Roadmap sets forth current HIE connectivity and exchange approaches across the nation, as well as federal efforts towards developing the foundation for interoperability and trusted HIE through common standards, services and policies.  It highlights those strategies for integrating these federal and private sector efforts, emphasizing the current progress that has been made and those challenges and barriers remaining to be overcome. 

Most importantly, it hopes to provide a roadmap of the major steps communities can follow to achieve progress towards HIE.  The HIE Roadmap states,

...Given the rapid market and policy changes and technology innovations occurring right now, there is confusion among healthcare stakeholders about how best to proceed with implementing HIE.  Leading HIE organizations are indeed charting new ground.  Emerging HIE efforts can and should learn from those who are further along in order to...leapfrog toward success."

It notes that in 2010, the number of public HIEs increased 81% from 37 to 67 with a whopping 210% increase in operating private HIEs, from 52 to 160.  Providing clear examples of leading HIE efforts, their leverage of national standards for exchange, and other factors contributing success, the HIE Roadmap seeks to capture the vision for why HIE is important to improving patient care and to the performance of our healthcare system, as well as provide a framework and a path forward for those working towards achieving HIE in their communities. 

The HIE Roadmap highlights several of the most notable challenges and barriers to HIE, including:

• Funding and sustainability;
• Variations in implementation of interoperability standards;
• Provider adoption;
• Disparate EMRs; and
• Privacy and security concerns.

However, it recognizes that these challenges and barriers are being "tackled and overcome."  The HIE Roadmap highlights ONC efforts towards building a foundation of interoperability and trusted exchange, in particular, recommendations of the HIT Policy and Standards Committees and their workgroups, such as the Meaningful Use, Information Exchange, and Privacy and Security Policy Workgroups.  It highlights the importance the Direct Project and the Nationwide Health Information Network (NHIN) continues to play in developing a strong interoperable foundation and the potential the Direct Project and NHIN have to promote best practices, compliance with existing national standards and implementation recommendations, and following through responsibility to protect health information.

The HIE Roadmap describes the approaches taken by several HIE initiatives across the nation, including:

• Care Connectivity Consortium, comprised of five leading health systems, Kaiser Permanent, Mayo Clinic, Geisinger Health, Intermountain Healthcare and Group Health;
• HealthBridge, with 50 participating hospitals, 800 physician practices, and 7,500 physicians;
• Indiana HIE (IHIE), with 90 hospitals and 19,000 participating physicians;
• Inland Northwest Health Services (INHS), with an air ambulance collaborative, rehabilitation hospital, and IT management for 38 hospitals and EMR services for 750 physicians, and which also partners with the Departments of Defense and Veterans Affairs; and
• Kaiser Permanente, which includes the Kaiser Foundation Health Plan and subsidiaries, 37 hospitals and over 450 clinical facilities, and the Permanente Medical Group Practices.

While highlighting the various strategies implemented by these initiative, the HIE Roadmap also recognizes that,

Indeed, interoperable HIE is a journey without a definite endpoint.  Many different approaches are being used, stakeholders are at different stages along this journey, and there is by no means a "one size fits all" model. 

It notes, however, that a key priority of many of these initiatives is to provide standards-based services to small physician practices, recognizing that most healthcare is delivered in these physician practices and the challenges they face.  Finally, the HIE Roadmap sets forth four major "steps" or phases for implementing successful and sustainable HIE, which starts wtih developing the HIE's objectives and vision.

In conclusion, the HIE Roadmap states,

The ultimate goal of HIE is to ensure that the right information is available at the right time and place every time to support the delivery of high quality, well coordinated, and cost effective patient-centered healthcare.  Keeping a consistent and clear focus on what is best for the patient is above all else the smartest way to stay on course in the ever-changing environment of HIE.

To me, the name “HealthTap” immediately implied an iPhone or other smart phone appplication or “app” like TapFish, a virtual aquarium, or TapFarm – a likely deliberate marketing scheme to tap into (pun intended) the success that apps have had.  With apps to calculate the amount of calories you burn, fitness workouts, curing acne, and instant access to WebMD and WebMD Baby, consumers are turning to app downloads for solutions to their health problems.  As we all know too well, there’s an app for pretty much everything (and indeed, there is, in fact, a HealthTap app). 

I freely admit that I, like many others, don’t think twice about consulting WebMD and the like before my physician for any health questions I may have.  The availability and wealth of information and the ease which consumers can obtain it is a powerful attraction and a driving force behind over 9,000 health apps being available in the iTunes store.  Like many others, I generally only consult sources that to me appear reputable and from a trustworthy individual or organization. 

At first glance then, HealthTap appears to be an applaudable solution to help individuals become more involved in their health care and seek answers to general health questions.  HealthTap states that,

We help you better understand your health, make better health decisions, and find the best doctors...We believe that everyone has the right to free, reliable, and independent health information. We also believe that the most trustworthy health information comes from medical experts. Finally, we believe that the best health decisions take into account unbiased expert knowledge, community insights, and relevant data.

Individuals can log on and create an account, either as a physician or as a member.  A member can pose a question which any physician that signs up for HealthTap can answer.  For each question answered by a physician, he or she is granted points and levels, building his or her “reputation” in HealthTap.  Answers can be categorized as “Yes”, “No”, “Maybe”, “Complicated Question”, “Evaluation” and the like.

Because answers are only coming from a physician with supposed knowledge and expertise, not a random individual like with Yahoo Answers, it appears to be more credible and trustworthy.  In addition, HealthTap gives you information on physicians active on HealthTap who are in your area and their field or speciality.  It may give you their practice location and affiliations as well so you can choose to “follow-up” with a particular physician who answered your question if you so choose, establishing a bona fide physician-patient relationship. 

As Millenson also points out, HealthTap also markets itself to physicians as a way to generate new business.  Its website states, “Build your reputation while attracting new patients and improving quality of care in an enjoyable and socially impactful way.” Notably, HealthTap also offers certain "elite clubs" with "preferential placement and highlighting of answers" and access to the HealthTap blog to publish articles for the HealthTap audience.  It is unclear, however, though just how invitations to or membership in these elite clubs is determined: payment of a membership fee or reaching a certain HealthTap reputation level.

On the one hand, I am fairly optimistic that a majority of physicians truly wish to help empower patients and share their considerable knowledge and expertise simply out of this desire.  Sharing this expertise online and through apps is an efficient mechanism to reach a larger group of individuals and communities, potentially affecting broader population health in a positive way.   I am also generally supportive of asking and making available answers to general health issues and questions. 

On the other hand, I am inclined to also agree somewhat with Millenson that motives may be questionable, as well as in general the reliability and trustworthiness of their answers. As he puts it,

You’re getting a few sentences of free medical advice from a group of random physicians, with reputations attested to by other random physicians, who are taking the time to answer your question for free either because of a desire to generate new business or a desire to help their Fellow Man.

After browsing around HealthTap, and giving it some thought, I almost agree with Millenson that HealthTap and other similar platforms may not be too different from receiving advice from a random stranger on Yahoo Answers or the first page "Googled" to that looks somewhat respectable.  While only physicians may provide answers, how do consumers know that the information they receive is accurate and reliable? Is it really possible for physicians to provide advice to an individual whom they have never seen and received only a few sentences describing a general health problem or question with little clinical relevance or clarity?  And even if the individual’s question is perfectly clear (which from a random sample of questions I viewed most certainly may not be), can a physician ethically provide reliable and clinically reasonable advice when limited to a 400 word response?

HealthTap isn't the only social media culprit that presents these problems.  The recent push for email exchanges between patients, Facebook and Twitter, posting "wiki's" and other informational sources online, blogging and participation in other online health forums all can create similar concerns for the physician-patient relationship, despite the wealth of infomation they can make available almost instantly.  For an article touching on a host of other issues presented by physicians increased use of social media platforms, such as malpractice, fraud and abuse, privacy and professional concerns, see Health Care Social Media: How to Engage Online Without Getting In Trouble and its Part II. 

Millenson cites a recent post on an internist's dissolutionment with blogging, quoting the physician as follows, 

Mostly everyone has either sent or received an email in which the content somehow did not fully convey the point intended. Despite reading, and rereading the message, the intent of the email was never fully apparent. I often felt that my responses were clear and concise, only later to learn that further clarification was required….In the end, the potential back and forth that can occur with email often resulted in the need for an office visit in order to clarify the mess that was created from the original email.

As Millenson goes on to note,

Maybe that’s the point. By consistently providing just enough information to be confusing, HealthTap may hope to provoke a significant number of users into paying to see a participating doctor and, presumably, persuade a significant number of participating doctors into paying HealthTap for that referral. Form follows function.

I can certainly see the benefits and potential that HealthTap and similar health apps and online resources have to help achieve broader patient involvement and understanding in their health care, prompting them to seek care from their physicians and specialists where necessary.  These apps, to some extent, may contribute to revolutionizing health care and patient involvement. 

On the flip side, however, a site promoting "real physician advice" and "no waiting room" may lead to a false sense of trustworthiness and accuracy and a host of other concerns.  A quick "type-and-tap" is not a substitute for real physician evaluation and advice or that physician-patient relationship, and for many, the waiting room just might be the better option.

SAMHSA Administrator Pamela S. Hyde stated,

Electronic health records improve quality, accountability, and cost effectiveness of health care services.  Persons with behavioral health problems often have significant physical health issues as well.  These grants are a critical down payment on the health information technology investment needed to ensure behavioral health service providers are fully interoperable with the general health system.

Among the awards are one-year $200,000 grants to 47 community health centers working to integrate primary care with behavioral health services.  A $3.8M grant award to the National Council on Community Behavioral Health Care was also announced to assist state and community health centers with implementing EHRs. 

Integrating behavioral health data with primary care data is critical to coordination of care.  The new grants will be instrumental in developing the much-needed HIT infrastructure necessary for the exchange of behavioral health information among providers and health care facilities.  SAMHSA is actively working with ONC to address policies and standards concerning the unique needs of behavioral HIT adoption and information exchange. 

For more information and the list of grant recipients, visit SAMHSA's official news release here.  

The plan sets forth five key goals for the federal health IT agenda towards better technology, better information and the transformation of health care across the nation:

• Adoption and Information Exchange through Meaningful Use of Health IT
• Improve Care, Improve Population Health, and Reduce Health Care Costs through Use of Health IT
• Inspire Confidence and Trust in Health IT
• Empower Individuals with Health IT to Improve their Health and the Health Care System
• Achieve Rapid Learning and Technological Advancement

The plan highlights current and future strategies and objectives undertaken by ONC and HHS to broaden privacy and security policies, achieve widespread transparency in how patient information is used and disclosed, increase patient access to information and education, and establish additional standards to support more advanced use of health IT.  In addition, it focuses on the key role of meaningful use of health IT through the Medicare/Medicaid EHR Incentive Programs. 

It also sets forth key policy areas to be addressed by HHS, including but not limited to: individual choice to participate in health information exchange, access limitations and transparency for electronic health information exchange, and secondary uses of health information for quality improvement, public health and research purposes. In addition, the plan highlights the need to improve technological solutions to allow for granularity of patient consent and data segmentation and current ONC efforts through its SHARP program to develop innovative means for doing so.  

Overall, the ONC's strategic plan is aggressive but by no means the end to planning.  As progress continues to be made, ONC will openly revisit, assess and update the plan as needed in coordination with federal, state and private and public stakeholders. To read the full plan, visit ONC's website.    

Last week, ONC opened a thirty-day window for organizations to apply to become the sole accrediting entity to oversee certifying organizations under the Permanent Certification Program for Health Information Technology (“Certification Program”). The Certification Program ensures certain electronic health record ("EHR") technology includes required capabilities for participation in the Medicare and Medicaid EHR Incentive Programs, which provide incentive payments to certain eligible health care professionals, hospitals and critical access hospitals that demonstrate meaningful use of certified EHR technology to adopt and utilize EHRs (“Meaningful Use”).

Currently, EHR vendors must be tested and certified by one of six ONC-approved entities (ONC-Authorized Testing and Certification Body or ONC-ATCB) under a temporary certification program implemented to ensure certified EHR technology was available for incentive payments beginning this year. Vendors who seek ONC-ATCB certification of their EHR technology as either a “Complete EHR" or an “EHR Module” must demonstrate compliance with certain capabilities, standards, implementation specifications and certification criteria. Once EHR technology has been ONC-ATCB certified, it can be used by health providers and hospitals to meet applicable meaningful use requirements. Complete EHRs provide all applicable certification criteria and the minimum capabilities a participant needs to comply with Meaningful Use. They may also include additional functions. EHR Modules, on the other hand, meet at least one, but not all, of the required certification criteria, and a combination of EHR Modules may be used to comply with Meaningful Use.

With the Final Rule for the Certification Program issued this January, accreditation and oversight is placed in the hands of the ONC Approved Accreditor or ONC-AA, which will be selected competitively every three years. The ONC-AA will be responsible for overseeing the ONC-ATCB entities and accrediting the Authorized Certified Bodies (ONC-ACB) under the Certification Program. Competing organizations for the ONC-AA will have to show what their proposed requirements would be for accrediting the ONC-ACBs, how surveillance of certified EHR technology would be conducted, their requirements for key personnel conducting the accreditation, and investigation and responding to complaints about ONC-ACBs. They also must show how they would adhere to ISO/IEC17011:2004 and experience with ISO/IEC Guide 65:1996, standards developed by the International Standardization Organization that specify general requirements for approving conformity assessment organizations and for product certifying organizations.

The ONC-ACBs replace the ONC-ATCBs created by the temporary certification program. Although ONC-ATCB status ends upon the sunset of the temporary certification program, certifications issued by ONC-ATCBs through the 2011/2012 payment years do not need to be re-certified for those years until ONC-ACB certification processes are in place.

The Notice for submission of requests for ONC-AA status may be found here.