In the past few years, we’ve seen headline after headline marveling at the advancements of medical technology. From wearable tech and micro sensors to 3D printing and health-oriented apps, it’s evident that technology and medicine have merged into an industry that’s pushing healthcare to a new level.
Yet many in the health tech industry are also voicing concerns about government regulators and their standards for healthcare technology. Some have even gone as far as accusing the FDA of “stifling” the creativity of healthcare tech and hindering the value these devices and apps could bring to the public.
In early 2014, legislation was introduced in an attempt to redesign the regulatory framework for certain types of technologies and lessen the FDA’s control over this growing industry. But are the FDA’s standards and actions so bad?
I’m in the tech field myself, and while I’ve heard many arguments against the FDA’s regulations, I strongly feel that it’s completely within its rights as a regulatory agency to place limits on medical technology. The FDA’s standards are put in place to protect consumers and to correct disingenuous manufacturer claims — an alarmingly frequent trend in today’s digital world.
Continue reading “Are Federal Regulations Stifling Disruptive Healthcare Technologies in the US?”
Filed Under: OP-ED, THCB
Tagged: App Store, Entertainment Purposes Only, FDA, Regulation
Aug 28, 2014
Health care providers and consumers are increasingly using mobile technology to exchange information. Many health IT providers readily acknowledge that some level of oversight is required to ensure patient safety and privacy protections, but many providers question whether the FDA is the right agency for the job and want to see the FDASIA recommendations.
Can the FDA, with its already limited resources and lengthy review cycles, regulate the fast-moving health IT industry? Should it? Health IT is fundamentally different from a medical device in many ways. For oversight purposes, the key differentiator between the two is the opportunity for clinical intervention in the use of health IT. Many medical devices interact directly with the patient (such as an infusion pump or pacemaker). Most health IT, on the other hand, merely provides information to clinicians, who ultimately make independent, experienced care decisions. Physicians are informed, but not controlled, by the information. This leads to a vast difference in the patient risk proposition and rigid regulatory oversight is not appropriate.
Advocates of a broad health IT oversight framework – which encompasses mobile health IT – are urging the FDA to delay release of its final guidance, particularly in light of a July 2012 Congressional mandate for the creation of a comprehensive oversight framework that avoids regulatory duplication.
But some mobile medical application developers are pressing the FDA to move forward immediately, believing its guidance will reduce the regulatory uncertainty that they believe is stifling innovation and investment in some aspects of mHealth.
Continue reading “Regulating Health IT: When, Who, and How?”
Filed Under: Tech, THCB
Tagged: Apps, athenahealth, Dan Haley, Epocrates, Esq., FDA, HIT, mHealth, Rebecca L. Jewell, Regulation
Sep 10, 2013
I have been absent from the blogosphere for about two months. The fact is, there just isn’t all that much new to write about. Healthcare spending growth continues to moderate, but not by enough to stave off forecasts of doom for Medicare and Medicaid. Nor can employers begin to shift money from health benefits back into wages. But wheels are turning. Health networks are expanding as providers prepare to offer ACOs and/or increase their bargaining clout. A handful of states are poised to start up exchanges with the feds ready to take the reins in the laggard states. Aon/Hewitt is about ready to launch a private sector exchange. We will start to learn whether exchanges save or destroy private health insurance.
The Affordable Care Act has had many detractors but at least it has disrupted the status quo. We needed to see fundamental changes in how we pay for and deliver healthcare services and the ACA has delivered. But ACA has brought us a very particular set of changes. Time will tell if we have chosen the right path.
Even as the industry changes the way it does business, one critical aspect of change is missing. The faces are all the same. The same large systems that dominated the fee for service world seem poised to dominate the shared savings world, and the same insurers that dominated the traditional employer-based insurance market stand ready to dominate exchanges. Value might be created when old businesses play by new rules, but even more value is created when new players are free to enter and perhaps even break the rules.
Entry is the engine that drives economic progress. Entrants bring new technologies to manufacturing and new service models to sales. Threatened by entry, incumbents strive to innovate and improve customer service. This is as true in high tech industries as it is in the service economy. Research confirms that entry is ubiquitous – in a typical manufacturing industry, fully one third of established firms are replaced by entrants within five years. Though the data is not as readily available, turnover in the service sector is likely even higher.
Continue reading “Unleashing the Innovation Monster”
Filed Under: OP-ED, THCB
Tagged: Anti-kickback laws, Aon/Hewitt, Certificate of Need, David Dranove, economic progress, EHR, Innovation, Regulation, The ACA, Wal Mart
Jan 16, 2013
Tomorrow the Presidential election process comes to an end and the advertising will finally stop. We’ll all be relieved. I especially look forward to a quiet dinner at home without robotic election-related calls.
What about healthcare IT? Will differences in the Obama and Romney platforms impact the momentum of Meaningful Use?
Here’s what I believe.
The Obama Healthcare IT platform builds on what we’ve created over the past few years. It will continue to leverage the federal advisory committees (Policy and Standards) to engage a wide array of stakeholders. It will persist the progression to Meaningful Use Stage 3 and possibly future stages. It will embrace certification now the temporary certification process has been replaced with a permanent one. It will support the initiatives of the Standards and Interoperability framework (S&I), although the end of stimulus funds from ARRA means that ONC will move some of the S&I initiatives to private/public partnerships. It will support the current leadership at ONC – Farzad and his delegates such as Steve Posnack, Doug Fridsma, and Judy Murphy.
The Romney Healthcare IT platform notes that Healthcare IT is an issue which has broad bipartisan support. No one argues that a foundation of healthcare IT implemented properly is essential for accountable care organizations. Quality, safety, and efficiency all benefit from the process enhancement afforded by healthcare IT. Michael Leavitt, former Secretary of HHS and chair of the American Health Information Community (AHIC) will lead the Romney transition team and Leavitt has years of experience with healthcare IT issues from the early days of ONC. As Governor of Massachusetts, Romney supported the early EHR rollout efforts of the Massachusetts eHealth Collaborative.
Continue reading “The Election and Healthcare IT”
Filed Under: OP-ED, THCB
Tagged: HITSP, Interoperability, Meaningful Use, Michael Leavitt, Obama, ONC, Regulation, Romney, Stimulus, Vendors
Nov 5, 2012
Doctors of my generation have experienced dramatic changes in the way we access the information we need to care for patients.
As a medical student 15 years ago, my “peripheral brain” consisted of fat textbooks sitting on office bookshelves or smaller, spiral-bound references stuffed into the bulging pockets of my lab coat. As a doctor-in-training, I replaced those bulky references with programs loaded onto PDAs. Today, smartphone apps allow health professionals at all levels to access the most up-to-date medical resources such as drug references, disease-risk calculators, and clinical guidelines—anytime, anywhere.
Apps have several advantages over traditional medical texts. First, the information is always current, whereas many textbooks are already dated by the time they hit shelves. If I have a question, I can look up the answer on my smartphone without leaving my patient’s side. And unlike textbook chapters, many medical apps have interactive features that help doctors choose appropriate screening tests for patients, recognize when immunizations are due, or calculate a patient’s risk of developing heart problems.
Lastly, apps can enable remote monitoring of high-risk patients and reduce the need for office visits. In a small study published in PLoS ONE, for example, researchers found that patients hospitalized for heart vessel blockages were able to complete “supervised” rehabilitation exercise sessions in their homes with a portable heart monitor and GPS receiver that transmitted real-time data to doctors via smartphone.
Continue reading “Medical Apps: The Next Generation”
Filed Under: THCB
Tagged: Apps, Archives of Internal Medicine, ECG, FDA, Patient Safety, Regulation
Aug 23, 2012
The Supreme Court’s decision upholding the ACA is deliciously ironic. The “individual mandate”–an idea promoted for everyone in the 90s and for Massachusettians (?) in the 2000s by the arm of the Republican party known as the Heritage Foundation–was found to be legal. But not as a mandate, instead as a tax.
Put aside for a minute the dreadful political contortions required to get this quasi-universal health insurance bill past Congress in the first place. Put aside the fact that the supposedly non-political Supreme Court hands down decisions time after time that are a pure reflection of the exceedingly public extreme political views of its justices. Put aside for a minute the fact that the ACA has undeniably kickstarted a round of changes in the health care delivery and insurance system that at least has the potential to lower costs and improve care, and that the luncay of politics meant we nearly lost that momentum.
Instead focus on what the Supremes have done. They’ve cut through decades of rhetoric about how we pay for health insurance and clarified it thus: we pay for health care via taxes–whether they are private taxes on employers and employees (and now individuals) or public ones on citizens.
Continue reading “Heritage & Roberts decree, all the world be taxed”
Filed Under: Matthew Holt, THCB
Tagged: Heritage Foundation, John Roberts, Regulation, SCOTUS, Taxes
Jun 28, 2012
During the health care reform debate, we wrote that most people’s attitudes to it were “confused, conflicted, clueless and cranky.” A major reason was that the American health care “system” is fiendishly complicated and few people really understand it. As a result hardly anyone knows much about what is actually in the reform bill (but that does not prevent them from having strong opinions about it). Sadly, the reforms, whatever their merits, will make the system even more complicated, the administration more Byzantine and the regulatory burden more onerous.
The American healthcare system is already by far the most complex and bureaucratic in the world. We were once asked to spend ninety minutes explaining American health care to a group of foreign health care executives. Ninety minutes? We probably needed a few weeks. Most other countries have relatively simple systems, whether insurance coverage is provided by a government plan or by private insurance or some combination of these. But in the United States insurance coverage, for those who have it, may be provided by Medicare Parts A, B, C, and D, 50 different state Medicaid programs (or MediCal in California), Medicare Advantage, Medigap plans, the Children’s Health Insurance Plan, the Women, Infants and Children Program, the Veterans Administration, the Federal Employees Health Benefits Program, the military, the hundreds of thousands of employer-provided plans and their insurance companies, or by the individual insurance market. This insurance may be paid for by the federal or state governments, by employers, labor unions or individuals. Some employers’ plans cover retirees, others do not. The result is that the system is pluralistic, mysterious, capricious and impossible for most patients and providers to understand.
The administrative complexity is amplified by the multiplicity of insurance plans. About half of all Americans with private health insurance are covered by self-insured plans, each with its own plan design. Employers customize their plan documents, led by consultants who make a good living designing their plans and tailoring their contracts. As one prominent consultant told us recently, if all the self-insured plan documents were piled on a table they would not just exceed the 2,700 pages of Obamacare, they would probably reach the moon. For the rest of the commercially insured population, health plans may be traditional indemnity plans, Preferred Provider Organizations or Health Maintenance Organizations.
The coverage provided by different plans varies dramatically. They may or may not include large or small deductibles, co-pays or co-insurance. Beneficiaries may pay a large, small or no part of their health insurance premiums. Some plans cover dependent family members and children, others do not. The Medicare Part D pharmaceutical benefit plan involves a “doughnut hole,” which will disappear as health reforms are implemented. Surveys have found that few people fully understand their own insurance plans let alone the bigger picture. While health reform takes some steps toward standardization of insurance offerings and improving transparency, overall it is likely to increase complexity. Continue reading “The Incredible and Wasteful Complexity of the US Healthcare System”
Filed Under: OP-ED, THCB
Tagged: Complexity, Doughnut Hole, Harris Poll, IPAB, Regulation, US Healthcare system
Mar 24, 2011