February 2010
Epstein Becker & Green, P.C. and The Anson Group formed the Connected Health Practice in 2009 to help our clients successfully develop and commercialize innovations in health information technology (HIT). The Practice has identified the following top ten critical issues that companies participating in the increasingly networked health care system will face in 2010.
1. What is the definition of "meaningful use"? The government's incentive payments for the adoption of EHR technology may create more problems than they solve. Qualifying for the incentive payments under the proposed "meaningful use" regulations, under the Health Information Technology (HITECH) legislation, is important for most health care systems and physicians. However, based on government estimates, the cost of mitigating existing EHR systems to comply with new regulatory requirements will likely meet and/or exceed expected incentive payments. Those that stand to lose the most under the new meaningful use requirements may very well be early adopters of EHR systems. Suppliers of technology will obtain certification of their new products in order for their customers to receive incentive payments; however, there remain a large number of legacy EHR systems for which there is no clear certification pathway. By 2012, the government's patchwork of regulations, incentive payments and penalties may turn out to do more harm than good.
2. How should companies track the development of the "Health Internet"? The establishment of the National Health Information Network (NHIN) has attracted a great deal of attention. Despite the fact that the new meaningful use regulations presuppose some type of functioning health information exchange, it remains to be seen how far NHIN will expand beyond its initial charter to provide standardized health information exchange, the gateway and interface, for private organizations that need to exchange health information. There remain some key problems to be solved: (i) who should be permitted access to what information and under what circumstances; (ii) what type of technology should be used to authenticate users (some type of private key/public key system is a likely choice but it would need a certificate authority); (iii) whether the network will have a decentralized or centralized (government controlled) architecture; (iv) and how to capture the many variations of a single persons medical record for litigation management purposes. Unfortunately, many local health information exchanges, and likely the NHIN itself, continue to face adoption and sustainability questions that may be further complicated by the shift in power in the Senate as a result of the special election in Massachusetts.
3. How will the National Broadband Plan support and promote health care delivery? Under the American Recovery and Reinvestment Act, $7.2 billion was allotted to grants for expanding the deployment of broadband, high-speed network technologies across the United States. One of the specific requirements of Broadband Technologies Adoption Program (BTOP) was for the Federal Communications Commission to discuss in its plan guidelines how these investments would support and promote health care delivery. In 2010, the federal government will debate whether there will be a dedicated spectrum for body area networks and other medical specific wireless technologies, as well as the quality of service requirements that will accompany the expansion of remote monitoring.
4. Will there be 'Net neutrality? In a similar vein, the increasingly tense battle between content providers, such as Google or Yahoo, and infrastructure providers, such as cable or telecommunications companies, was not definitively settled in 2009. It is unclear whether companies that invest money to provide the critical infrastructure and bandwidth will be required to carry all traffic on an equal priority basis, regardless of source, or whether they will be able to selectively charge more for higher quality service level commitments. Whichever decision is rendered, possibly in 2010, it will have a significant impact on remote monitoring and other connected health initiatives that rely on the Internet to connect patient's homes with health care applications or devices. Net neutrality may create a disincentive for infrastructure companies to invest in new technology necessary to support the ever increasing demands of information-hungry consumers. Because reliability is essential for any type of connected health care system, Net neutrality may undermine the reliability of the Internet as a means for communicating patient information. Ensuring competition in the cable and telecommunications industry is a better use of the government's resources.
5. Are software applications like electronic medical records considered medical devices, and will they be regulated by the Food and Drug Administration (FDA)? Companies that sell health care software that is installed in hospital and physicians offices continue to operate like any other commercial software company. The FDA has not clearly communicated its intentions about oversight of the multi-billion dollar HIT industry. However, in 2010, we may have more insight into this issue, as well as the industry's response, since the pressure is mounting for the FDA to provide guidance. The FDA probably will avoid doing anything to clarify its intentions for at least a couple of more years or until a serious incident arises such that Congress demands the FDA take action in this area.
6. Should companies connect medical devices with Electronic Medical Records and other clinical software applications on hospital enterprise networks? Every participant in the health care system stands to benefit from extending interoperability beyond different health record systems to device interoperability with other devices and a patient's health record. Much information was published about this in 2009, including both benefits and challenges. Considerations to be addressed in 2010 include shared risk-management responsibilities between hospitals and device manufacturers, as well as regulatory compliance, security, privacy, and quality of care impact. The uncertain legal privacy landscape will likely serve as a roadblock to extending and building interoperability of medical devices with EMRs or Personal Health Records (PHRs).
7. Will the government expand the Health Insurance Portability and Accountability Act (HIPAA) enforcement? While most of the attention regarding the HITECH legislation has been on the billions of incentive dollars for the implementation of electronic medical records, the expansion of HIPAA enforcement penalties to apply to business associates of covered entities has been increasingly publicized. In 2010, the additional risks to private health data as they traverse various network connections will be a primary concern for companies responsible for their care, regardless of their status as a covered entity or not.
8. How do you validate the reliability of smart phones and clouds? From one end of the spectrum to the other, technology innovation presents challenging issues along with the benefits that typically consume most of the press. Whether it's a diagnostic imaging application on a smart phone, or the resulting image stored in "the cloud," both represent new challenges to validating the integrity and reliability of the resulting data when it comes time to use it in diagnosing the patient's condition that must be addressed in 2010.
9. Who "owns" the data in an electronic health record? The secure, inter-operable network of electronic health information will include medical records from providers, along with ancillary data from personal health record Web sites, employers, or payer-provided systems. The aggregation and consolidation of all of these disparate data sources ultimately comprise the overall health profile of the individual. It remains to be seen how data rights and access to the data will be provisioned.
10. How long will it take to see real results? Health care reform has dominated the public debate, along with the legislative drama around it. Maintaining and continuing the momentum for the successful integration of health care and technology will be an important issue going forward, even after the buzz about wireless monitoring, electronic records, and meaningful use begins to subside.
The Connected Health Practice is dedicated to the vision of helping important innovative technology reach the market successfully in spite of the critical issues that we have presented above. There is no going back to paper.
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This "Life Sciences Top Ten" was authored by Dane Stout of The Anson Group. The author thanks EpsteinBeckerGreen attorney Robert Hudock. For additional information about the issues discussed in this "Life Sciences Top Ten," please contact the author or contributor, or the EpsteinBeckerGreen attorney who regularly handles your legal matters.
