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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.

So you’re all about creating the best IT-based solution to disrupt healthcare. Whether you’re a entrepreneur with a brilliant idea or a programmer bringing an idea to life, the success of your efforts will have to be aligned with the regulatory landscape of health IT legislation and regulation– and most companies need help sooner than they think.

Paying close attention to legislation and regulation might seem unnecessary, but a healthy comprehension of the environment can truly define the success of your company. Your customers, whether health organizations, health providers, or patients and families all have to function within these legislative and regulatory parameters to be reimbursed by health insurers (of which CMS is the largest) or gain access to valuable information. In addition, they have to comply with these laws to ensure that they can access pertinent data and not be in danger of non-compliance, i.e., fines or more. In order to prevent even the hint of impropriety your customers will rely on you for the highest and clearest compliance. If your product or company fails to meet the requirements for data collection, exchange, and use, then not only could you fail to attract users, but you could be held legally responsible.

The regulatory world is a busy one, and not everything will be relevant to your business all the time. That said, being aware of  crucial details in bills or regulations early in your business model formation or product design can keep you on the right track — unawareness can derail, even halt, your business once you begin to sell or scale. Knowing some basics will give you the solid foundation for knowing what to pay attention to, when and why it will impact your business, and how to get involved along the way.

Legislation versus Regulation, What’s the difference?

Legislation:

The first step the government takes to dictate how something should work (i.e., how Health IT should function or be used or how health data should be collected, exchanged, or used) is to pass a law. This process happens in Congress on the federal level and state levels. The U.S. Congress and each state has their own state-level legislatures where laws are introduced and voted on by members of the corresponding legislature — these are one area of early influence for you. Advocates and lobbyists educate legislators and their staff on issues and help craft possible language for the bill on your behalf.…but more on that later in this series. A newly introduced bill often has a long road, sometimes years, before the possibility of becoming a law and many factors go into how far a bill progresses. In D.C. we often colloquially ask if a bill “has legs,” — does it have the potential to actually get passed and become a law. Getting passed means the bill received enough votes in both the representatives’ and senators’ chambers and was signed by the President (for federal laws) or by the state governor (at the state level).

Things to keep in mind:

1. Just because a bill was introduced doesn’t mean it will become the law of the land—However, it can give a sense of current social and political sentiment and can give a lot of insight on potential obstacles.

2. Often a bill on a single issue, regardless of how important, will not be passed unless it becomes part of a larger bill addressing many concerns. This means that when a larger bill is passed, it’s important to work with experts to understand the smaller subsections that might affect your business. This is one of the most pertinent examples of the phrase “the devil is in the details.”

3. Even when a bill is passed, it often serves only as an outline to how an industry will need to function. Think “broad strokes.” The legislature usually points to a government agency to provide further details on how that law will be put in action. These action plans are what we call regulations. This means that there are limited items to enforce until the corresponding agency releases further instructions of do’s and don’ts in regulatory language.

Regulation:

Regulations, by any government agency, are not simply penned and released. A long, methodical, thoughtful process precedes any regulation’s release, which normally follows this order:

1. A Notice of Proposed Rulemaking (NPRM) —This is where the government agency releases a draft rule, often after the agency holds multiple public hearings or workgroups to hear from stakeholders. An NPRM is not law, but can give you a clear idea of what the final law may look like. Any release of a draft government rule is usually accompanied by a public comment period, typically between sixty and ninety days, where the agency is looking for further comments from industry stakeholders on the feasibility and acceptability of the rule. This is another place you can get involved in shaping the regulatory landscape to advocate that the law represents your business needs and goals. We’ll cover more on this in part 2 for this series, “Why, how and when to get involved in the regulatory process.”

2. A Final Rule — Once a final rule is released, it becomes the law of the land, until the agency decides to update the regulation. Some regulations are updated every year—such as CMS’ physician pay schedule. Others may not see an updated version for decades. Recognizing the constantly evolving world of technology, most agencies that deal with health IT recognize the need for more frequent regulatory updates. The most important thing  to note in any final rule is the enforcement date. Enforcement dates usually start downstream from when the final rule is released, allowing the industry time to become compliant before any fines or penalties come into effect.

Things to keep in mind:

1. Public comments are actually read at least at a “batch level” by government officials. This means that government officials, often long-term employees, have a stake in seeing that rules can be successfully enforced with a positive impact on an industry. So they will at minimum survey how many stakeholders are either for or against a stance in the draft rule.

2. Health IT laws are a combination of policies (how a health application should or should not be used) and technical specifications (how a health IT application should work, be designed, or what minimum capabilities it should have.) Both policies and technical specifications outlined in regulations can have an impact on your health IT or health IT-enabled business.

3. Understanding whether you fall into the “business associate” or “third-party” definition in regards to your relationships with health providers will directly affect how regulations will affect your business and your revenue generation models.

4. There are other levels of draft rules, government guidance, and regulatory communications that can be used. Working with regulatory experts, such as Elevation, will help you determine the impact of governmental requirements on your business models and product designs.

This is a big week for those who care (or should care!) about health data tech regulation. The day before the biggest health IT conference of the year, HIMSS, the U.S. Department for Health and Human Services (HHS) dropped two highly anticipated draft rules—one outlining the seven exceptions to information blocking (i.e. when does not sharing data not count as information blocking) and the other requiring health plans to release Medicare and Medicaid claims data through openly published Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®)–based Application Programing Interfaces (APIs). These draft rules along with anticipated changes to HIPAA suggested in the 2018 HIPAA Request for Information (RFI) signal a landmark period of immense change to the domestic regulatory landscape regarding collecting, using, and exchanging health data. Without a strong working knowledge of new health data privacy laws being released here and abroad in 2019, your business could be jeopardized by missteps on the regulatory landscape. For the first blog of this series, we will set the stage with some important facts you need to know about the 2018 HIPAA RFI and the European Union’s (EU) General Data Protection Regulations (GDPR)—arguably the first chapters of this new data-sharing story.

Three Facts About the Current HIPAA Regulations

Most people don’t realize that the “P” in HIPAA stands for portability. HIPAA was intended to help data liquidity, not hamper it. But the rules are often misinterpreted, and in some cases, ignored. Here are a few things that should be on your radar:

1.       If you’re selling your application to a patient via a healthcare organization or healthcare provider, you are considered a business associate and are subject to HIPAA regulations. The HHS Office of Civil Right (OCR) has some great guidance on figuring this out. That means you have to safeguard the health data coming through your technology according to HIPAA privacy and security rules.

2.       Business associates and covered entities are equally liable for a data breach. Protecting patient data must be paramount to any organization who is handling personal health information (PHI).

3.       If you fall under the business associate category, resale of health data for revenue generation is illegal without explicit authorization from the patient (and allowance in your contract with the covered entity to resell data). If you’re not in the business associate category, for example, you are providing a freestanding app directly to patients, you should still consider transparency and patient data privacy as fundamental guiding principles to establish trust with your clients to ensure the longevity of your applications I’ll talk about this more as we discuss what’s happening in the EU.

Changes to Anticipate in HIPAA

HHS is focused on making it easier for individuals to get access to their data. The OCR RFI has a strong focus on shortening the time period it takes to make that happen (e.g. less than the current thirty day allowance). Though some may argue with HHS on the level of patient data that’s easily available in a certified EHR via a C-CDA or FHIR API, folks can expect HHS to continue to push for quicker access to larger amounts of data for patients.

In addition, OCR is revisiting accounting for disclosure requirements and trying to determine whether more can be done to provide transparency to patients regarding who their data is being shared with for treatment, payment, and operations. OCR seems to be signaling  that transparency into what is shared and with whom will be pivotal for building and maintaining patient trust as larger amounts of patient data are shared across a growing number of entities.

Why You Should Care About the EU’s GDPR

The GDPR was passed by the EU to bring data privacy rules into the twenty-first century. Unlike HIPAA, the GDPR covers all data about an individual, not just their health data, though health data is specifically highlighted. In addition, unlike HIPAA, the GDPR specifically states that an individual’s data is owned by that individual. The GDPR gives individuals the “right to be forgotten,” meaning they can ask companies who hold their data to delete it and, in essence, forget the individual. Here are a few reasons why the GDPR is something to be watched and understood by the U.S. tech industry:

1.       The success of the GDPR in the EU has been noticed by U.S. lawmakers.  Already in the current congress, at least two privacy framework bills have been floated around.  Although it may still take a few more years to see similar U.S. laws passed at the federal level, California has passed a law similar to GDPR for their state and New Hampshire has had a longstanding law that explicitly gives patients ownership of their data.  So, if you are selling to the California, New Hampshire, or EU markets, you have more than HIPAA regulations to consider.

2.       It’s always difficult to balance data sharing with privacy. Developing revenue-generating health tech that enhances data liquidity while giving the individual choices on how and where their data moves is the holy grail. Two ways to weave this into the fabric of your company’s data principles are:

a.       Be transparent and consistent in your data use policies. Building trust with your customers is key to long term success. In addition, remember that national and state data-sharing policies are moving in the direction of stricter controls on how you can use data not loser ones.  Being ahead of this curve can help establish your leadership and dominance in an ever-growing consumer-driven health ecosystem.

b.       Consider building paid options within your business model that allows individuals to pay to use your services with dollars instead of their data. Though some individuals may be more open to allowing the sale of certain types of their data for access to free or discounted technology, many people are more protective about their health data and may prefer to pay for your services in exchange for their data privacy.

Addition note – Though not specifically linked to GDPR, this week Germany’s Federal Cartel Office ruled that Facebook’s practices of mashing user data with other data sources and using it to customize and sell ads is an unfair practice that the social media giant must discontinue. They noted that most individuals did not understand how their data was being used by Facebook and that forcing users to agree to these practices in order to use the platform was exploitation. While Facebook will most certainly appeal this decision, it signals a growing trend towards more data protections, not less.

Moving Forward

The OCR HIPAA RFI is just one lever regulators are using to push the industry towards sharing larger amounts of health data electronically. The OCR HIPAA RFI, the HHS Office of the National Coordinator for Health IT’s (ONC) 21st Century Act proposed rule on Information Blocking, and the Centers for Medicare and Medicaid Service’s (CMS) Interoperability proposed rule are all interrelated, and any company that is focused on sharing or using health data must pay close attention to each of these rules or risk running up against various scalability issues including possible government fines.  Our next blog will focus on ONC’s Information Blocking proposed rule, so stay tuned.

So you want to build the next best app-based telehealth solution? Great, the world needs you! But working through Washington DC’s never-ending lists of legislation and regulations to identify which will maximize return on your efforts is like unlocking a code. Incorporating national and state regulatory requirements into your prototype design can be the linchpin to the successful expansion of your company. Lucky for you, we’ve got the key! In today’s installment, we’re going to lay out some key regulations that touch the telehealth sector that you should definitely keep your eye on:

THE NAME: HR 6- SUPPORT for Patients and Communities Act

THE BASICS: Passed on June 22nd this year, HR 6 was mainly focused on addressing the opioid crisis, but has two key provisions that affect telehealth. First, it expands access to telehealth service for Medicare recipients living with an opioid disorder. The previous regulation for reimbursement restricts telemedicine usage to rural patients and also limits which services they can use. These requirements can now be waived by the Secretary of HHS. HR 6 also establishes a requirement for electronic opioid prescriptions. Overprescribing, fraud, and abuse are some of the root causes of the opioid crisis, and all could be greatly reduced by electronic prescribing. This will also provide better data and traceability of the crisis which could be leveraged by hospitals, drug companies, insurance companies, and health tech companies to fight the epidemic.

THE TAKEAWAY: Momentum behind solving the opioid crisis will push further reimbursement of telemedicine and eventually adoption by a larger swath of the market. Considering how your solution can be leveraged to address opioid abuse issues may open up partnerships with upcoming federal or state pilot funding for you.

THE NAME: MACRA

THE BASICS: MACRA stands for Medicare Access and CHIP Reauthorization Act of 2015, and is also often called the Permanent Doc Fix. What it did was create a new payment framework for Medicare based on quality rather than volume of service. This is huge for telehealth platforms, because their improved access to care alongside higher patient engagement and compliance certainly improve value of care practitioners are able to provide. MACRA also specifically mentioned telehealth services as being applicable for satisfaction of MIPS (Merit-Based Incentive Payment System) requirements.

THE TAKEAWAY: Telehealth solutions have the opportunity to not only maintain quality of care but also improve both outcomes and volume through data driven care and tech efficiencies. Can your product allow providers to offer enhanced quality in their care with decreased in-person “encounters?” (See how Babyscripts is accomplishing this in our previous blog.)

THE NAME: HIPAA

THE BASICS: Passed in 1995, this law regulates how protected health information (PHI) can be stored and transferred electronically. HIPAA law applies to any health care provider (HCP), their vendors/suppliers, and business associates who have access to PHI. The guidelines and standards establish privacy and security procedures for handling PHI which, if not followed, can result in financial and criminal penalties for the responsible entities. Telehealth solutions must be built with HIPAA compliance in mind, since any use of PHI opens up users and companies to HIPAA liability. Physicians must enter into business associate agreements with technology providers to remain compliant, and must subject vendors to the same HIPAA standards.

THE TAKEAWAY: From inception, all tech solutions should keep HIPAA privacy and security standards at the forefront of development. Failure to do so could result not only in lost business, but also financial or criminal penalties.

THE NAME: “Meaningful Use”

THE BASICS: Though not an acronym, the phrase “Meaningful Use” has a very specific definition when used in reference to electronic health records (EHR) and telehealth. Meaningful Use defines the minimum standards for EHR and data exchange between patients, HCPs, and insurers. Providers must comply with the standards in order to receive funding from Medicare/Medicaid through their EHR incentive program. As we’ve said before, improved patient portals and remote records access for higher patient engagement is critical for health tech products. Hospitals will need to improve their metrics to show compliance with Meaningful Use, and will be looking for products that meet these requirements.

THE TAKEAWAY: MU patient engagement requirements are an opportunity for app developers to create improved graphical user interfaces (GUI) to allow patients to review their health data. Intuitive GUIs and built-in metrics for telehealth solutions will be the keys for hospitals and providers to better engage with their patients and use these telehealth solutions to meet MU requirements. 

THE NAME: FCC

THE BASICS: Shorthand for Federal Communications Commission, it’s the FCC’s job to regulate interstate communications by radio, television, wire, satellite, and cable. In 1996, congress passed the Telecommunications Act, directing the FCC to promote the deployment of advanced telecommunications capabilities nationwide, especially so that rural health care providers have access to affordable and reliable services for telemedicine. As we covered in part 2, the best telemedicine solutions still need reliable broadband internet. The FCC has some initiatives to assist rural HCPs with discounts and improved access to high-speed internet. Most importantly, the FCC recently announced intentions to release around $100 million in funding to promote connected health through solutions such as telehealth.

THE TAKEAWAY: Timing is everything. Follow the FCC’s connected health funding announcements for pilot funding opportunities. How can you offer— on its own or in partnership with other businesses— a full end-to-end solution for improving health outcomes in a remote environment? Remember that remote describes care delivered via technology-based modalities regardless of the distance over which it is delivered.

THE NAME: 21st Century Cures Act

THE BASICS: This act was passed in December 2016 and intended to prevent information blocking, which includes practices that “interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.” These rules are intended to speed up the drug, device, and medical technology (including telehealth products) approval process so patients have access to treatments sooner. The main reason to be interested in this regulation is that it promotes interoperability for electronic health information and seeks to penalize entities which inhibit interoperability of health data to which they may have access. The final definitions for information blocking are due out in September 2018, which we will cover as they are released.

THE TAKEAWAY: Currently viewed mostly as a fringe capability, telehealth should and is moving toward mainstream health care. This act solidifies working definitions of interoperability and information blocking, which are central to advancing the adoption and proliferation of telehealth. Great telehealth solutions are designed to collect, store and exchange data seamlessly with other healthcare technologies, especially EHRs. New health data standards like FHIR have huge potential and deserve your attention.

It’s a lot, we know! But armed with information about current and upcoming regulations your tech will be more resilient to potential liabilities at launch and beyond.

If you haven’t yet read part one, we encourage you to go back and read about some of the reasons telehealth makes sense not only today, but for the future of healthcare. Today we want to address some practical components necessary for any health data technology to have viability, longevity, and scalability in the future landscape of telemedicine.

What do we want? Data! When do we want it? At the point of care! And also now…

Chances are, if you’re tuned into the news at all, data comes up in some capacity almost daily. Data has become the thing we all want- whether businesses looking to improve profits, health consumers looking to have maximum engagement, or health care professionals wanting to provide care to patients that actually improves outcomes. Data is at the heart of any health-tech solution; and the ease of data sharing and interoperability are essential to successful telehealth products.

Physicians need full access to patient data at the time of each telehealth encounter. And whether the source is electronic health records or connected medical devices, access to meaningful data gives physicians a full picture of the patient’s health story, thus improving their diagnostic ability. When data exchange occurs entirely and instantaneously, a physician does not have to gather data that already exists during patient interactions, making appointments shorter. If data feeds viewed by providers offer concise actionable data, physicians can streamline their decision-making, giving them a greater return on their time invested. And when physicians provide better care in less time, it means higher compensation within a value-based care system. The key is to create seamless data access and exchange for a seamless telehealth experience.

Telehealth platforms need to provide health consumers with access to data about the care they receive. Whether in a portal or separate application, the data on these platforms must be meaningful, up to date, automatically uploading, and easy to find and understand.  Patients should be able to share information with their providers and correct inaccurate data. The goal is to empower patients to ask questions, search for further information from trusted resources, and be engaged in their health.

We’ve updated our privacy policy…

The more data that we include in electronic records, the higher protection people will want for that data. If it’s true of our photos, usernames, and email, then it’s even more important for health data. Health tech companies must guard against threats to privacy and security at the highest level when handling and storing health data that, ideally, paints a robust picture of each patient. Fully integrated security solutions will be essential for product development, which means prioritizing a complete understanding of the governing regulations on cybersecurity and software development in regard to data protection.

Gen Z, and Millennials, and Boomers, oh my!

One of the snags a telehealth company might hit is a dissonance between their target demographic and early adopters of their technology. While most millennials are willing, if not eager to digitize all aspects of their lives, the patients using the most resources in the health care system are the elderly. Older patients often have multiple chronic conditions or comorbidities and require frequent appointments, tests, and procedures as part of routine care. The benefits of telehealth for the elderly are massive given the market opportunity and potential cost savings, but one of the largest obstacles of adoption will be usability. Telehealth solutions might require a level of technological literacy, so UX design for older patients is critical. Whether that be larger format compatibility for tablets to ensure easy visibility, AI chatbots and instructional videos for guided use, etc., robust customer support is paramount to ensuring proper use of the product and positive health outcomes.

Which is not to say that UX improvements couldn’t be made across the board. All users, regardless of age, need usable online portals. Patient engagement with such portals is notoriously low because of unintuitive interface or convoluted design. And even when patients figure out how to navigate through them, the portals are often very limited in their functionality. Upgrades to UX could improve adoption of telehealth solutions and extend continuum of care beyond the doctor’s office. And on the other end, applications designed with the health care provider in mind could improve workflow, reduce training requirements, and even reduce the chance of medical errors.

Can you hear me now? Good…

We are all familiar with current video conferencing capabilities and failures. In a 5-10 minute remote appointment with a provider, there is no room for buffering, poor sound quality, or reconnecting. Companies must learn from these common frustrations and design for all levels of internet access- rural and urban, PC and cell phone- but plan for when those technologies fail. Utilization of phone, text, email, apps, video-sharing, and video conferencing will allow the widest reach of technology in telehealth.

Searching for devices…is your device discoverable?

We’re in the middle of a health technology revolution where the line between consumer products and medical devices blurs more daily. The internet of things and connected devices create the potential for immediate connection between patients and health care providers. Wearables like Fitbit or Dexcom provide up-to-the-second monitoring of patient vitals that allow a more complete vision of patient health to be built. Recreationally, consumers are generating their own data, and health tech companies need only create a space to utilize this data. The most successful company will be the one that integrates hardware and software smoothly, which will generate high quality data for better products and health outcomes.

Next up: What federal legislation, regulations, and programs are important to incorporate into telehealth-based solutions?

Now that we’ve given you a primer on Atul Gawande, we want to dig more into the company he’ll be heading and offer insights on aligning with this upcoming venture.  (If you missed our introduction to Atul, we strongly suggest you go back and read why we’re so excited.)

 

What we know:

Bezos, Buffet, and Dimon are still very tight-lipped about the venture, but have divulged that it will be a company aimed at providing health care to their employees. Their motives seem to be both ideological and financial. The company, which they describe as “free from profit-making incentives and constraints,” will attempt to provide both better services and more manageable costs for their health care.

 

It’s no surprise that another group is taking aim at health care in the US; the country spends more than 17% of its GDP on care but doesn’t achieve the same health outcomes as many other nations. If you’re reading this, chances are you already know what’s broken, and that there are many ideas on how to fix the health care system, but that no one has yet managed to solve the problems on a large enough scale to make a difference nationally.

 

Already we see the venture beginning to take shape. Yesterday Amazon announced the acquisition of online pharmacy PillPack, a Boston-based company (with pharmacy licenses in all 50 states) that offers pre-sorted and dosed packages of medications shipped to customers’ homes with options to refill and renew prescriptions. This move fits Amazon’s pattern for disrupting the industries it enters by streamlining the supply chain, and we can glean insight into the direction of its new venture based on the company’s history.

 

What this means for patients:

It almost goes without saying that Amazon is known for disrupting industries. The company has solved the world’s biggest supply chain problems and shaken up competitors from online sales to cloud infrastructure services, artificial intelligence to, most recently, groceries with the acquisition of Whole Foods last summer. As the largest provider of cloud infrastructure services, they stand poised to scale any technology they develop immediately. Also a trailblazer in AI, they could lead the shift toward connected health. And Bezos will guide the company toward efficiencies even if it means cannibalizing current companies along the way. For the health care patient frustrated with inefficient and rising costs, this is a great thing.

 

Health care in the US is a difficult-to-follow supply chain managing the flow of goods, data, diagnoses, medicine, money, and more. It’s not always clear who the customer is- from a pharmaceutical perspective, doctors are the customer as much as the patient because they need doctors to prescribe their products. After surgeries or major medical expenses, hospitals negotiate pricing with insurance companies rather than the patients receiving care.

 

Amazon, alongside other heavy hitters like Google or Facebook, maintains its dominance through data. They make sure they know who their customer is, what goods that customer is interested in, when a product is ordered, when it arrives, and if the customer was satisfied. The potential uses for such data harnessing in health care are massive: given a specific person with a specific medical history, what devices or medications are they likely to need or want?

 

What this means for the health tech developer:

With Atul at the helm, these business titans will be looking for the most cost effective way to provide good health care. Practically, that means they will begin gathering data or looking for people to gather data better for them with the ultimate goal of simplifying data collection.

 

Certainly there are inefficiencies to be found. Some hospitals and clinics still don’t use electronic health records, and the ones that do aren’t connected in a useful way. Today the fax is our standard for communication of a person’s medical history, but technologies like block chain could be the next step toward totally decentralizing health record transmission.

 

Traditionally, health data is generated sporadically by a doctor or health care provider during visits that occur mostly at the patient’s discretion, and the player that ends up with the largest swath of medical data is the insurance company. Many insurance companies are working to leverage this data to grow the margin between cost of care and profitability, and they are looking for developers to help them provide high quality care at lower costs. Throwing more data into the mix, the advent of smartphones, wearables, and IoT devices could give doctors unprecedented access to continuous health monitoring outside the office.

 

In discussing his reasoning behind the venture, Dimon has emphasized the impact of incentivizing people toward wellness to reduce the development of serious (and expensive) illnesses. We read this as an obvious call for products, especially apps, that emphasize fitness tracking, diet, nutrition, and other healthy lifestyle behaviors. Today’s health tech developers are focused on getting more data in a more novel way than their competitors in order to attract medical device, health technology, and health care companies like the Amazon/ Berkshire Hathaway/ JPMorgan Chase venture. Developers should look to incorporate national data policies and standards within their plans; leveraging such policies and standards to promote interoperability of data can make or break scalability for new apps or software.

 

What we hope:

Though traditionally health insurance companies pay for health care, Amazon, Berkshire Hathaway, and JPMorgan Chase are major employers who can throw their weight with big insurance. Under Atul’s guidance and with Amazon’s business model, they will no doubt be seeking out data in order to identify and eliminate inefficiencies in health care delivery. With both money and influence behind the project, they have the option to micro-target individual inefficiencies or make changes on a grand scale to disrupt the health care industry in the US for good.

 

For those who don’t know, Amazon, Berkshire Hathaway, and JPMorgan Chase have come together on a health care venture that has health tech entrepreneurs watching very closely. Part of the interest is, let’s be honest, a result of the sheer capital potentially involved, and part of it is that the details of the project remain largely a mystery. But on Wednesday, Atul Gawande was named its new CEO and if you haven’t yet heard that name, here’s why it matters:

 

A renowned surgeon and New Yorker health policy contributor, Gawande has made his name focusing on simple, self-professed “unsexy” solutions to health care needs. In his newest book, The Checklist Manifesto (currently on eight bestseller lists), he looks to other high-risk industries like aviation to find opportunities for improvement where trained specialists and state of the art technology already exist. Gawande finds that even among highly specialized work, perhaps especially so, implementing a checklist allows for pause points to reassess that everything has been completed correctly before moving on to the next step. And while it might sound obvious, when his checklist was implemented in eight hospitals in as many countries, all eight saw drastic reductions in both complications and deaths in surgery.

 

In the spirit of Gawande’s emphasis on health care operating as an efficient system where many voices must find a consensus in order to address health needs, we have gathered our top five ideas from his extensive work that we hope he brings to the new company (and hopefully as a result, the nation’s healthcare landscape at large):

 

Pit Crews – We tend to think of the physician as the sole authority on diagnosing and treating patients, the specialist most of all. We romanticize the autonomy and self-sufficiency of a world-renowned surgeon as the highest form of medical care professional the way we romanticize cowboys in the Wild West. But Gawande, a well-revered Harvard pedigree doctor himself, tells us that the cowboy’s ego and hyper-competitiveness are easily beaten by the pit crew’s evidence based and consensus decision-making. In his essay “Cowboys and Pit Crews” in the New Yorker, Gawande states that “medicine’s complexity has exceeded our individual capabilities as doctors.” This extends beyond just hospitals to the government agencies and companies that provide health data and analytics. Group thinking, decision-making, and treatments lead to better care for patients.

 

Data – Though they seem simple, checklists don’t come out of thin air. It takes extensive research and data compilation to even begin the process of learning what steps are necessary, in which order, and where mistakes are likely to happen before you arrive at error prevention. Data supported decision-making is a foundational belief of those of us drawn to the sciences, yet it has somehow lost its prominence in our thinking, regulation, and legislation. Gawande would have us return to our roots; looking always to research and data as a leaping-off point, rather than a final step to confirm our beliefs. “Medicine has become the art of managing extreme complexity” he writes in The Checklist Manifesto, “and a test of whether such complexity can, in fact, be humanly mastered.” Not by any one individual or any isolated perspective maybe, but perhaps through the relentless seeking of data to anchor our knowledge, innovations beyond what we thought possible can be achieved.

 

Incremental Health Care – Gawande stresses that high cost does not equal best care. In his New Yorker article “The Heroism of Incremental Care,” Gawande chronicles his own change of heart regarding the impact that rescue medicine versus regular maintenance and incremental diagnostics make in a person’s life. Surprisingly, though we often throw the bulk of our resources at surgeons, cardiologists, and the like, it is the primary care physician that makes the greatest difference in mortality rates and quality of life. Gawande admits his pull to the hero aspect of being a surgeon and rescue medicine, but asks us to reconsider which fields we most revere with our hearts and our funding, highlighting the nurses, nurse practitioners, primary care physicians, and general clinicians. And to Gawande, this isn’t a matter of opinion. “We can give up an antiquated set of priorities and shift our focus from rescue medicine to lifelong incremental care,” he states unilaterally, “[o]r we can leave millions of people to suffer and die from conditions that, increasingly, can be predicted and managed.”

 

Charisma – If it isn’t yet clear, Gawande has a way of taking a look at the most inscrutable, difficult to parse problems in healthcare and unraveling them into a clear, beautifully written essay that appeals to both the humanity and business aspects of health care. Chances are, if you’ve had an idea of how to improve the health care system, Gawande has said exactly what you thought, but more succinctly, with compelling narratives and vulnerable anecdotes to boot. With all the other expertise he has going for him, his written and oratory skill could be overlooked, but we would disagree! When health care discussions sometimes feel dead in the water before they even begin because of the varying opinions on what and how to fix, the massive amounts of data necessary, and the emotional charge from each of our individual experiences within the health care system, a little charisma can go a long way to getting everyone around the table.

 

DATA – Say it again for the people in the back! Data is vital, and without emphasis on it, none of the complex problems in healthcare can even begin to be addressed. As entrepreneurs in health and technology, it is important to base innovation in the data available and also to seek out new data – the more, the better! Only by collecting the full picture can we begin to zoom in to individual needs within the health care sphere. We hope admitted data champion Atul Gawande brings this issue to forefront; he is clearly one of the great health policy minds of this generation, and we are excited for what he comes up with next!

 

Now that we’re all better acquainted with Atul, stay tuned for our next blog, where we hash out what you should be doing in response to his appointment…

Cancer is undoubtedly one of today’s deadliest diseases with the American Cancer Society anticipating that over 1.7 million new cases will arise while over 600,000 people will lose their personal battle with the disease just in 2018 alone. The need for patients, providers, and health researchers to be armed with tools that will effectively and optimally fight cancer is more critical than ever. This is where health tech entrepreneurs come in: solutions are needed and you are the ones who can build them.

The APOLLO Network, a tri-federal agency initiative stemming from the Cancer Moonshot, grew out of such a need. In this post, I am both pleased and excited to feature an interview with Cancer Moonshot’s Dr. Jerry Lee.  Dr. Lee is the former Deputy Director for Cancer Research and Technology for the White House Cancer Moonshot Task Force and current Deputy Director for the National Cancer Institute’s (NCI) Center for Strategic Scientific Initiatives.

Jamie: Jerry, thanks again for joining me. If you wouldn’t mind, could you give a quick description of APOLLO? What is its purpose?

Jerry: APOLLO stands for Applied Proteogenomic Organizational Learning and Outcomes. It is a collaboration between the NCI, the Department of Defense (DoD), and the Department of Veterans Affairs (VA) aimed at creating the nation’s first healthcare enterprise where proteomic analysis complements genomic sequencing in cancer patients to inform targeted decision making. More simply it is meant to track cancer patients and survivors in both the DoD and VA systems, following them through their cancer care and beyond to glean what treatments are most effective for each individual. Currently, we are working towards collecting data on a combined cohort of 8,000 patients within the VA and DoD systems. Having started with lung cancer, we are now expanding to additional cancer types, including cancers of the ovary, endometrium, prostate, and breast. As the program grows, our goal is to continually generate new information that will boost the clinician’s ability to treat the disease.

Jamie: If a health tech innovator wants to design a next generation solution aligned with the APOLLO mission, what would you suggest they prioritize?

Jerry: I’d say there are really three key components that make up the APOLLO ideology: precision medicine, interoperability, and health outcomes. Precision medicine is all about customizing healthcare to fit the individual. Through proteogenomic analysis, we get a better sense of the molecular basis of each patient’s unique cancer and are able to make informed decisions about targeted therapies. In this way, proteogenomics has become a keystone of precision oncology, and we use its findings to refer patients to the appropriate clinical trials. But precision is not just based on proteogenomics alone.  Another major factor is imaging (including CT, PET, MRI) which we use in conjunction with proteogenomics to triangulate upon the problem. Pre and post treatment images are taken of the same APOLLO patients that have had his or her tumor sent for proteogenomic analysis in order to see the effect the recommended therapies have on the tissue and the patient. This data and these images help us illuminate major points in a cancer patient’s journey, whether that be survivorship or recurrence. 

In order for digital data to impact patient care, this data needs to be exchanged accurately and efficiently. Part of this is ensuring semantic interoperability right from the start. If the end goal is to see patients using apps and data platforms to share data and get information and treatment options specific to their individual profiles in a timely fashion, then we need systems across the board all speaking the same language. For precision oncology, this includes interoperability of cancer specific genomic, proteomic, imaging, and clinical data.

At the end of the day, the most important part of all of this is the health outcomes. APOLLO is, at its core, creating a learning healthcare system and it is through these outcomes that we learn and adapt. We gain insights about effective therapies and long-term patient outcomes that would simply not be possible without the APOLLO network. 

Jamie:  Finally, what advice would you give to innovators looking to build precision oncology data tools?

Jerry: Don’t reinvent the wheel. It’s something I constantly tell my staff and something that absolutely applies here. Use what has already been done. Take advantage of the data that’s publicly available, through the NCI Genomic Data Commons, Proteomic Data Portal, and Cancer Imaging Archive or engage with a fellowship program, such as BD-STEP, and have a chance to work with the data first hand in the VA system, including data from APOLLO. We are dealing with a world where data needs to be accurate and flow quickly. Having multiple, inoperable libraries only hinders progress as we move towards finding effective intervention strategies for active duty, beneficiaries, veterans, and civilian cancer patients. 

Additional Resources:

https://proteomics.cancer.gov/programs/apollo-network

https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2810

http://onlinelibrary.wiley.com/doi/10.1002/cpt.658/abstract;jsessionid=032755370412D3CF7BEE6E1012FC8171.f04t02

Acknowledgements: Special thanks to Mary Kozlowski and Sarah Elder of NCI who helped to pull together the resources for this post; for more information about anything contained in this article, please email kozlowskimt@mail.nih.gov.

From the time I peered through the nursery room window watching my mother, a neonatal ICU nurse, take care of premature babies, my life has been devoted to improving health.  My journey has taken several forms since then: cardiac nurse, pediatric nurse, medical researcher, federal health grants program founder and director, national health policy wonk, data scientist, research data infrastructure developer, and now, new entrepreneur.  I‘ve chuckled many times at young graduates when they ask me how I got to where I am today…I had a theme, no doubt, but I could never have predicted the pathway.  I remain committed to improving health outcomes by promoting the efficient, effective and secure mobilization of health data and to advance health research and care continuity. 

Richard Stearns, (the) president of World Vision, an over $2 billion-dollar faith-based humanitarian aid, development, and advocacy organization, recently gave a talk that inspired me.  Instead of taking the opportunity to pull heart strings with the myriad of un-met basic human needs across the world, he delivered a powerful and positive message of the great forward strides global relief efforts have made to eliminate extreme poverty. There is certainly much work to do, but often with simple non-sexy solutions like a water wells and hygiene education, you can save hundreds of thousands of lives.  Often the hardest hurdle to bringing about change isn’t the creation of the solution itself, but building awareness, consensus, and adoption of potential solutions.

I hope to bring a similar message of positivity and inspiration to work together and push to “keep-on-keeping-on” for our efforts in creating health technology that can save lives.  I believe my role here, in this blog, is to help with the awareness piece by highlighting exciting large-scale, national efforts that can be leveraged to bring new products to market that allow people to achieve their optimal health.  To be successful as a company and as a fellow warrior against death and disease is to understand the end user for whom you are creating – people like yourselves.  People don’t live to buy health technology. People want health technology so they can live longer and fuller lives, making and sharing memories with the people they love.  I hope the awareness I raise allows you as a health tech entrepreneur, like myself, to preserve precious R&D funds and leverage what already has traction.  To scale more easily and effectively from your first client to your 100th client and beyond.  Most of all, I hope that this approach enables you to create more highly integrated health tech solutions that work seamlessly in the background of every individual’s health story.