The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?
The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.
Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT.
I myself was encouraged by the report. It brings together a number of initiatives that have received little attention and, just by publicizing the issues, places us one step closer to a quality program. Particular aspects that pleased me are:
- The suggestion that quality programs should start to look at electronic health records (p. 8). EHRs have been certified by various bodies, but usually just to check off boxes and declare that the systems comply with regulations–neither the quality of their user interfaces nor the quality of their implementations have been questioned. Reportedly, the FDA considered “safety and quality standards” for electronic health records in 2010 but couldn’t get them adopted. It also checks certain forms of clinical decision support, but only if they are built into a regulated device. The current HHS report refers back to aspirational documents such as a Health Information Technology Patient Safety Action & Surveillance Plan and a set of guidelines on the safety of EHRs.
- A call for transparent reporting and sharing of errors, including the removal of “disincentives to transparent reporting”–i.e., legal threats by vendors (p. 25). Error reporting is clearly a part of the “environment of learning and continual improvement” I mentioned earlier. A regulation subgroup stated the need most starkly: “It is essential to improve adverse events reporting, and to enable timely and broader public access to safety and performance data.” Vague talk of a Health IT Safety Center (p. 4, pp. 14-15) unfortunately seems to stop with education, lacking enforcement. I distinctly disagree with the assessment of two commentators who compared the Health IT Safety Center to the National Transportation Safety Board and assigned it some potential power. However, I will ask ONC and FDA for clarification.
- A recognition that software is part of a larger workflow and social system, that designing it to meet people’s needs is important, and that all stakeholders should have both a say in software development and a responsibility to use it properly.
Don’t imagine that the FDA is unused to regulating software. For quite some time they have instituted practices for the software used in some medical devices , and have tried to keep them up-to-date.
A waterfall-like process of risk assessment and testing called computer system validation has long been required for pharma and devices.
Continue reading “Health IT: The Coming Regulation”
Filed Under: Tech, THCB
Tagged: Andy Oram, Device software, EHR vendors, FDA, FDA regulations, HHS, HIT, Medical Devices, Patient Safety, software errors
Apr 14, 2014
In the New York Times on Thursday, October 17, Topher Spiro wrote an important op-ed expressing why we need to hold onto the medical device tax that helps pay for parts of the Affordable Care Act. Spiro backs up his argument by pointing out how profitable the device industry is. To his argument I would also add the fact that this will provide the industry with more paying customers. Certainly it can afford to pay the taxes.
But I diverge from Spiro on a proposal he floated near the end of his piece:
“To complement these efforts, the new Patient-Centered Outcomes Research Institute [PCORI], a non-governmental body created by the Affordable Care Act, should pay for research that compares the effectiveness of devices so physicians can make informed choices. (Three years into its existence, the institute has initiated few, if any, studies of medical devices.”
Listen to me PCORI. Don’t follow this advice, unless you plan not to survive to celebrate your fourth birthday.
Consider what happened to the Agency for Healthcare Policy Research (AHCPR), when it tried to help physicians figure out the best way to treat low back pain. AHCPR was created as a stand-alone research institute, akin to the NIH, but one that would focus not on the basic science of treating disease, but instead on evaluating how well existing treatments worked.
Continue reading “Why PCORI Should Be Very Wary of Studying Medical Devices”
Filed Under: OP-ED, THCB
Tagged: AHCPR, Medical Device Tax, Medical Devices, New York Times, PCORI, Peter Ubel, The ACA
Oct 18, 2013
NEHI recently convened a meeting on health care innovation policy at which the Harvard economist David Cutler noted that debate over innovation has shifted greatly in the last decade. Not that long-running debates about the FDA, regulatory approvals, and drug and medical device development have gone away: far from it.
But these concerns are now matched or overshadowed by demands for proven value, proven outcomes and, increasingly, the Triple Aim, health care’s analog to the “faster, better, cheaper” goal associated with Moore’s Law.
To paraphrase Cutler, the market is demanding that cost come out of the system, that patient outcomes be held harmless if not improved, and it is demanding innovation that will do all this at once. Innovation in U.S. health care is no longer just about meeting unmet medical need. It is about improving productivity and efficiency as well.
In this new environment it‘s the science-driven innovators (the pharma, biotech, and medtech people) who seem like the old school players, despite their immersion in truly revolutionary fields such as genomic medicine. It’s the tech-driven innovators (the healthcare IT, predictive analytics, process redesign, practice transformation and mobile health people) who are the cool kids grabbing the attention and a good deal of the new money.
To make matters worse for pharma, biotech and medtech, long-held assumptions about our national commitment to science-driven innovation seem to be dissolving. There’s little hope for reversing significant cuts to the National Institutes of Health. User fee revenues painstakingly negotiated with the FDA just last year have only barely escaped sequestration this year. Bold initiatives like the Human Genome Project seem a distant memory; indeed, President Obama’s recently announced brain mapping project seems to barely register with the public and Congress.
Continue reading “Science-Driven Innovation and Tech-Driven Innovation: A Marriage of Convenience or a Marriage Made in Heaven?”
Filed Under: Tech, THCB, The Business of Health Care
Tagged: Big Data, Biotech, clinical research, Innovation, Medical Devices, NEHI, Pharma, Tom Hubbard, Triple Aim
Jul 9, 2013
With the announcement that the FDA granted 510(k) approval for the AliveCor EKG case for the iPhone 4/4s, the device became available to “licensed U.S. medical professionals and prescribed patients to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.”
While this sounds nice, how, exactly, does one become a “prescribed patient?” Once a doctor “prescribes” such a device, what are his responsibilities? Does this obligate the physician to 24/7/365 availability for EKG interpretations? How are HIPAA-compliant tracings sent between doctor and patient? How are the tracings and medical care documented in the (electronic) medical record? What are the legal risks to the doctor if the patient transmits OTHER patient’s EKG’s to OTHER people, non-securely?
At this point, no one knows. We are entering into new, uncharted medicolegal territory.
But the legal risks for prescribing a device to a patient are, sadly, probably real, especially since the FDA has now officially sanctioned this little iPhone case as a real, “live” medical device. But I must say, I am not a legal expert in this area and would defer to others with more legal expertise to comment on these thorny issues.
This issue came up because a patient saw the device demonstrated in my office and wanted me to prescribe it for them. So I sent AliveCor’s Dr. Dave Alpert a tweet and later received this “how to” e-mail response from their support team:
Continue reading “When Patients Can Obtain Their Own EKG”
Filed Under: THCB
Tagged: AliveCor, Dave Alpert, Dr. Wes, EKG, iPhone, Medical Devices, Workflow
Feb 16, 2013
Today, an intensive care unit patient room contains anywhere from 50 to 100 pieces of medical equipment made by dozens of manufacturers, and these products rarely, if ever, talk to one another. This means that clinicians must painstakingly review and piece together information from individual devices—for instance, to make a diagnosis of sepsis or to recognize that a patient’s condition is plummeting. Such a system leaves too much room for error and requires clinicians to be heroes, rising above the flawed environment that they work in. We need a heath care system that partners with patients, their families and others to eliminate all harms, optimize patient outcomes and experience and reduce waste. Technology must enable clinicians to help achieve those goals. Technology could do so much more if it focused on achieving these goals and worked backwards from there.
This week marks a step that holds tremendous promise for patients and clinicians. On Monday the Masimo Foundation hosted the Patient Safety Science & Technology Summit in Laguna Niguel, California, an inaugural event to convene hospital administrators, medical technology companies, patient advocates and clinicians to identify solutions to some of today’s most pressing patient safety issues. In response to a call made by keynote speaker former President Bill Clinton, the leaders of nine leading medical device companies pledged to open their systems and share their data.
Lack of interoperability between medical devices plays no small role in the 200,000 American deaths caused by preventable patient harm each year, such as in the case of 11-year-old Leah Coufal. After undergoing elective surgery, Leah received narcotics intended to ease her pain.
When Leah received too much medication, it suppressed her breathing, eventually causing it to stop altogether. Had she been monitored, a device could have alerted clinicians when Leah’s breathing slowed to a dangerous level.
But as we know, clinicians are busy and unfortunately don’t always respond to alarms from bedside machines. If a machine measuring her breathing had been linked with the device delivering her medication, it could have automatically stopped the drugs from infusing into her blue, oxygen-deprived veins.
All of this is possible today; technology is not a barrier. Until now, the only thing that’s stood in the way is a lack of leadership and a lack of willingness for device manufacturers to cooperate.
Continue reading “Connecting Medical Devices and Their Makers”
Filed Under: THCB
Tagged: Interoperability, MD, Medical Devices, Patient Safety, Patient Safety Science & Technology Summit, Peter Pronovost
Jan 18, 2013
A time-and-technology challenged FDA, proliferation of software-controlled medical devices in and outside of hospitals, and growth of hackers have resulted in medical technology that’s riddled with malware. Furthermore, lack of security built into the devices makes them ripe for hacking and malfeasance.
Scenario: a famous figure (say, a politician with an implantable defibrillator or young rock star with an insulin pump) becomes targeted by a hacker, who industriously virtually works his way into the ICD’s software and delivers the man a shock so strong it’s akin to electrocution.
Got the picture?
Welcome to the dark side of health IT and connected health. Without strong and consistently adopted security technology and policies, this scenario isn’t a wild card: it’s in the realm of possibility. This is not new-news: back in 2008, a research team figured out how to program a common pacemaker-defibrillator to transmit a “deadly 830-volt jolt,” according to Barnaby Jack, a security expert.
Continue reading “The New Bioterrorism? The Hacked Medical Device”
Filed Under: Uncategorized
Tagged: cyber attack, FDA, Health IT, HIPAA, ICD, Jane Sarasohn-Kahn, Medical Devices, Patient Safety, Security
Oct 23, 2012
In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide.
While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential harm they may be causing our patients.
As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths.
The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement. In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.
Continue reading “Why the Electronic Medical Record Needs to be Viewed as a Medical Device”
Filed Under: Uncategorized
Tagged: American Recovery and Reinvestment Act, Cerner, Data, Dr. Wes, EHR, FDA, Medical Devices, Medical errors, medications, Patient Safety, Reigel vs. Medtronic
Aug 20, 2012
We are disappointed that CMS’ recently proposed rules again miss a clear opportunity to address home hemodialysis access for Medicare patients.
Recent clinical research demonstrates the significant benefits of more frequent dialysis. Better clinical outcomes, lower mortality, and higher survival – the list goes on. Recognizing the strength of this data (and heeding the calls of numerous patient advocates), large national commercial insurers, including UnitedHealthcare and Aetna, recently clarified their policies, granting greater access to home, and more frequent, hemodialysis for commercial patients.
In recent weeks, CMS’ proposed rules for both Physician Fee Schedule and ESRD PPS Rule came out. In the proposed Physician Fee Schedule, physician payment will increase for in-center dialysis, but will remain essentially unchanged for home dialysis. Physicians are already paid generally 20% less to care for their home dialysis patients, and under the proposed rule for physician payment this disparity would grow. In the proposed ESRD PPS Rule, there were no mentions of home hemodialysis. None. In the rule, CMS proposes a 2.5% increase to the bundled payment rate, representing hundreds of millions dollars of additional money going to the Medicare dialysis program. None of this increase is going to address the known payment issues impacting access to more frequent home hemodialysis.
Continue reading “CMS Misses the Mark on Home Hemodialysis”
Filed Under: The Business of Health Care
Tagged: Aetna, Chronic Disease Research Group, CMS, Dialysis, ESRD, Home Hemodialysis, Joe Turk, kidney failure, Medical Devices, Medicare, NxStage Medical, Physician Payment
Aug 12, 2012
The jobs-killing Obamacare law contains 20 new or higher taxes on American families and employers. Many of these tax increases fall on families making less than $250,000 — a direct violation of candidate Obama’s promise not to raise “any form” of taxes on these families. In less than a week, the second anniversary of Obamacare being signed into law will take place. The Supreme Court will be hearing oral arguments about the constitutionality of Obamacare next week.
Out of the 20 new or higher taxes in Obamacare, there are five that fall most directly on seniors.
The first is the excise tax penalty for failure to comply with Obamacare’s individual mandate. Many seniors face a coverage gap between retirement and Medicare eligibility. Obamacare raises taxes on these younger seniors by punishing them if they don’t purchase “qualifying health insurance.” Set to go into effect in 2014, the excise tax penalty for mandate non-compliance will in 2016 rise to 2.5% of adjusted gross income for a senior couple (or $1,390 for those making less than $55,600).
Why does Obamacare raise taxes on seniors just as they are entering retirement? Many of these seniors will face this “stick” but find themselves with too much income to qualify for the “carrot” of tax credits to purchase Obamacare health insurance plans in an exchange. Many will be forced to keep working just to avoid paying this tax.
The second tax hike on seniors is the so-called “Cadillac Plan” excise tax. Starting in 2018, Obamacare imposes a whopping 40% excise tax on high-cost (“Cadillac plan”) health insurance plans. This is defined for seniors as a plan whose premiums exceed $29,450 for a family plan, or $11,500 for a single senior. Seniors often face higher costs in health insurance premiums due to chronic health conditions and other risk factors. This tax will fall almost exclusively on the seniors with the greatest health insurance needs.
Continue reading “The Five Tax Hikes in Obamacare that Most Hurt Seniors”
Filed Under: OP-ED, THCB
Tagged: Medical Devices, Taxes, The ACA
Mar 22, 2012
If they can hack your home computer, your mobile phone, apps, your store, your social networks, your bank account, your gaming system, your medical records, your school records, the government and its records, and pretty much anything anyone sets their mind to – isn’t it is only a matter of time until someone finds a way to hack your heart?
Not through a musical hook or melody that you can’t shake. Or a well timed smile by someone your soul connects with. Or a box of chocolates. Or a poem. People have been penetrating the human heart with those Luddite-ish tools since the beginning of civilization.
I was thinking more about that electronic device your doctor might have implanted into your chest to keep your heart beating. Or the little box stuck in your gut to help you and your pancreas regulate your diabetes. Or the mini-computer surgically inserted to keep your neurological systems on track.
Hacking the medical miracles put inside people to let them live longer with more normal lives.
While to my limited knowledge nobody has reported a single case and the likelihood is extremely low, it is a real enough concern that the New England Journal of Medicine published a paper about the need to improve security last year.
Continue reading “Hacking Your Heart”
Filed Under: THCB
Tagged: Medical Devices, Privacy, Security, Wireless
Jun 23, 2011