By now, you’ve got a solid understanding of a health IT entrepreneur’s strategic business need to stay abreast of health data regulations as they’re developed. If you understand the connection between regulatory alignment and business growth but are wondering “When should I engage in reviewing, responding to, and influencing regulations? And how do I do it?” this is the place for you! You’re probably familiar with federal statutes, and you’re well-versed in the release procedure of proposed rules and final regulations. (For a quick refresher check out Should Health IT Entrepreneurs Bother Knowing The Difference Between Legislation and Regulation?) Key to answering the questions of when and how to engage in proposed or enacted regulations, is knowing how governmental policies are created beyond the proposed rule process. Understanding the mindset of regulators at each step of the process towards a final regulation, will enlighten and guide you in knowing when and where you should invest your time in the regulatory sphere for maximum effect for minimum effort. This inside peek into the regulatory process is relevant to health IT policies and beyond.
Portrait of a Regulator — Let’s lay out an important fact: Your voice as an entrepreneur, developer, or funder in health IT is important because most policy makers don’t have your perspective informed by personal experiences. They have advanced degrees in public health, public policy, or administration. Health agencies, like the U.S. Department of Health & Human Services (HHS), have been wise to employ doctors, nurses, and other health providers who understand health care, but who often haven’t practiced on the front lines for many years and lack hands-on experience using current health technologies to enhance the care they’re providing. This, coupled with the speed at which technology evolves, ensures that regulators are very dependent on input from stakeholders to formulate and release policies that makes sense for the communities they regulate. Poorly formulated policies can hinder progress and limit innovation. To their credit, this is precisely why regulators usually release a series of requests for information (RFIs) and notices of proposed rule-making (NPRMs) before releasing a final regulation, called a “Final Rule”. Regulators need informed input based on current realities and they want room to self-correct if elements in a rule do not reflect real-world evidence. In their defense, they want to invoke positive change in the sector for which they are releasing the regulation.
Before Regulations are Written — Regulations reflect legislative mandates, administration goals, public sentiment, and lessons learned from federal program testing, unlike legislation (which we’ll cover in the next blog, “How You Can Influence Laws—A Forgotten Business Strategy”). Many times policy formation begins years before a regulation is written. Frequently, regulatory agencies, like HHS, will fund localized pilots to develop a policy concept and put it into practice in micro-environments, often referred to as pilot initiatives. These pilots are often the first place your company can have a hand in shaping policies. They usually begin with a phase called “use case development” where they invite public stakeholders to participate in defining what a real-world scenario looks like in industry workgroup or Federal Advisory Committees (FACAs). Voicing your business’ realities in these government-funded community groups ensures that the policy-testing grounds reflect your company’s capabilities as matched with your clients’ needs. This process helps ensure policies are tested and translated into future regulations that reflect the realities of your business model and the market. Although active participation in these workgroups, FACAs and pilot initiatives can be time consuming and not practical for small start-ups, it is valuable to follow these initiatives peripherally to keep apprised of the direction these pilots are taking, especially if the policies they are testing can affect your bottom line. It’s a savvy use of your time to meet with regulators during this phase to educate them on the value and workings of your company’s technology. Regulators rely on these educational sessions to determine what direction they want to steer policy formulation, or even more so, how far they can take a policy concept and still count on stakeholder support.
The Rule is Out, Now What? — As stated in the previous blog, regulatory language is not final until the Final Rule is released. The time period from the release of a draft rule (NPRM) to an enforcement date in a Final Rule can be years. Once a draft regulation is released and a public comment period is announced, government officials must wait to receive your feedback in writing via their public comment sites. During public comment periods, regulators are prohibited from meeting with stakeholders outside of official public meetings such as government-established town halls or public FACA meetings, such as those run by the Office of the National Coordinator for Health IT (ONC). Instead, this will be your opportunity to provide written feedback on elements of the federal regulations that affect your company’s business model. It is important to comment on both what you support as well as what you want to see changed in later drafts of the Rule, because regulators need to know what regulations help or hinder your company’s success and why. Once the comment period is over, regulators may be open to meeting with you again in person about a rule that has not yet been finalized. Once the Final Rule is out, the cycle sometimes begins again later when the Rule will needs to be updated. Some Rules, such as Medicare and Medicaid Physician Fee Schedules, are updated annually. Other rules, like HIPAA (released in 2003), stood for years before certain sections were updated in subsequent Rules.
It Still Seems Daunting—Help! — No one can be on top of everything, so don’t worry. You are the most knowledgeable voice on the technology you’ve created and the needs of your clients, and regulators are eager to learn from your experiences. Some Washington D.C.-based consulting and law firms, like Elevation, specialize in knowing pilot programs, federal rule making agendas, and release dates. Firms like ours can help you decide when, where, and how it makes the most sense to efficiently and effectively monitor and engage with regulatory activities that affect your company’s growth potential and bottom line. Elevation, in particular, specializes in health data technology policies and our team of experts have either led federal policy-forming initiatives or authored landmark health data regulations themselves.