President's column: two important decisions, one clear direction…

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With the Supreme Court upholding essentially all elements of the Affordable Care Act (ACA), a collective sigh of relief could be heard across the industry despite the ongoing frustration and disagreement with certain elements of the new law. We now have a clear decision. While the politicians may continue to debate portions of the Act, healthcare leaders and workers have a defined path. Change is the new watchword for healthcare.

While repeal is still a possibility, it is very remote. To accomplish a repeal, the Republicans must generate a perfect trifecta in the upcoming elections by maintaining control of the US House (likely), gaining control of the White House (a split decision at this point), and gaining control of the US Senate (again, a split decision at this point). However, most everyone agrees that even if Republicans gain control of government, the repeal of ACA would come in pieces rather than as a simple ‘repeal’ because the original law was passed as part of the reconciliation process. So, the focus of the industry must turn towards results. The decision is clear, but the direction of healthcare reform needs further definition.

For the informatics and health information technology (HIT) communities, the Supreme Court of the United States (SCOTUS) decision was an important milestone. It seems rather likely that the investment decisions we've made over the last several years through HITECH and other HIT initiatives will continue. Furthermore, the primarily bipartisan nature of the HIT agenda will set the stage for refocusing our attention almost exclusively on results.

We should anticipate that the healthcare industry will focus much more forcefully on population health strategies such as accountable care, patient-centered medical homes, bundled payments, and other evolving care delivery models. At the heart of all of these initiatives is the effective and efficient use of information technology. Informaticians and informaticists are key professionals for taking the information and creating intelligence to improve healthcare.

However, another important decision was overshadowed by the SCOTUS ruling. The Food and Drug Administration (FDA) finally issued a draft set of regulations that target the many evolving health-related applications which are increasingly deployed on smart phones and wireless tablets. These devices—which are already recognized by providers as useful tools for enhancing the delivery of care—have now garnered the interest of federal regulators.

The draft guidelines point to three areas where FDA approval of applications used by providers would be required: (1) oversight of mobile applications that act as an accessory to a regulated medical device; (2) applications that modify mobile devices into care delivery tools; and (3) applications that offer suggestions and/or advice regarding a patient's diagnosis or treatment. For example, an app that allowed radiologists to view digital films on an iPad or cardiologists to turn their Android phone into a heart monitor would be regulated. However, an app that simply stores medical records or provides educational training for physicians would not be regulated.

These are draft regulations and require our attention. As important as the SCOTUS decision was in setting a new direction for healthcare, I believe that how we regulate new, evolving, mobile technologies is of equal importance. In fact, mobile technology regulation—from my perspective—will have a much more profound impact on the direct delivery of care than virtually any other use of technology.

While the decisions are important, the direction is clear, yet murky. Reform of the healthcare delivery system is essential. What needs to be done is open to possibilities. When is absolutely clear. Now! How we do it will require multi-disciplinary models if we are to be successful. Who needs to help lead the effort? Again, informaticians and informaticists are key professionals for offering guidance on how we can use information derived from new technologies and create intelligence to improve healthcare. Our attention must now shift from decisions to directions for healthcare reform. It is an imperative.