By Andy Oram

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”

By THCBist

In a development that Washington insiders had been quietly predicting for months,  Kathleen Sebelius announced Thursday that she is resigning as HHS Secretary. Critics were quick to point to the disastrous launch of Healthcare.gov and the glitch-filled rollout of the administration’s signature health law.

President Obama is expected to nominate  OMB  Director Sylvia Mathews Burwell to replace Sebelius Friday morning.  The Washington Post notes that Mathews-Burwell is well regarded for her “strong management skills”  and cites her experience in global health after ten years with the Bill and Melinda Gates Foundation.

Politico reports that while publicly praising Sebelius for having overseen a late surge in enrollments that brought signups up to the 7.5 million mark  by the time she announced her departure today,  many Democrats are said to be privately “furious” about how badly the Obamacare rollout went and are worried that debacle could cost them control of the Senate in November.

If you’re curious about Burwell’s resume – after all – we’re talking about the woman who will (probably) be the official face of Obamacare until at least 2017 – WonkBlog did some digging back at the time of the hearings for the OMB job.

Continue reading “ACA Signups hit 7.5 million. Sebelius Steps Down. Mathews-Burwell to Lead HHS.”

By Alex Howard

The Obama administration announced significant adoption for the Blue Button in the private sector on Friday.

In a post at the White House Office of Science and Technology blog, Nick Sinai, U.S. deputy chief technology officer and Adam Dole, a Presidential Innovation Fellow at the U.S. Department of Health and Human Services, listed major pharmacies and retailers joining the Blue Button initiative, which enables people to download a personal health record in an open, machine-readable electronic format:

“These commitments from some of the Nation’s largest retail pharmacy chains and associations promise to provide a growing number of patients with easy and secure access to their own personal pharmacy prescription history and allow them to check their medication history for accuracy, access prescription lists from multiple doctors, and securely share this information with their healthcare providers,” they wrote.

“As companies move towards standard formats and the ability to securely transmit this information electronically, Americans will be able to use their pharmacy records with new innovative software applications and services that can improve medication adherence, reduce dosing errors, prevent adverse drug interactions, and save lives.”

While I referred to the Blue Button obliquely at ReadWrite almost two years ago and in many other stories, I can’t help but wish that I’d finished my feature for Radar a year ago and written up a full analytical report.

Extending access to a downloadable personal health record to millions of Americans has been an important, steady shift that has largely gone unappreciated, despite reporting like Ina Fried’s regarding veterans getting downloadable health information.

According to the Office of the National Coordinator for Health IT, “more than 5.4 million veterans have now downloaded their Blue Button data and more than 500 companies and organizations in the private-sector have pledged to support it.”

Continue reading “The Pharmacies and Retailers Say They’re In. Is the Blue Button Initiative About to Change Everything?”

By Paul Keckley

Last week, HHS issued its much-anticipated report about the first wave of enrollees in the state and federal health exchanges. Its release coincided with the 32nd Annual J P Morgan Healthcare Conference in San Francisco, arguably Woodstock for health care investors.

HHS reported that, as of December 28, 2.2 million signed up for coverage. They are older and probably sicker than the overall population of 50 million uninsured in the U.S.:

By Seth J. Chandler

The Department of Health and Human Services released updated data yesterday on enrollment on the Exchanges including, for the first time, greater breakdowns on enrollment by several key categories: age, gender, and the metal level of purchase.

The result of this long awaited and much requested data is, at first glance, very much a mixed picture. Some of the overall statistics do not look as problematic as some — including me — had feared they might be. But it looks as if there is a very serious potential for large adverse selection problems brewing in a number of states,  most notably West Virginia, Mississippi, Maryland and Washington State.

The good news for the ACA from the data

There are three major pieces of good news for those who support the goals of the ACA.

1. The overall gender distribution of enrollees, 54% female, 46% male does not appear on preliminary inspection to be sounding “red alert.” To be sure, the problem may be a little greater than would otherwise be suggested by the aggregated numbers if the middle age group is more heavily female and the oldest group of enrollees more heavily male that the aggregated numbers suggest.  And Mississippi is troubling with 61% female enrollment (and for other reasons, see below).

But, overall, and if they hold up, these do not appear to be the the kind of numbers that would be way beyond what insurers likely expected or that, standing by themselves, would be devastating to an insurer on an Exchange.

2. Several states have total enrollments and the age distributions that should reduce the possibility of a serious death spiral getting started. New York and California are the two big states doing better than most.  Connecticut is doing very well also.

3. The metal tier distribution is 80% for Bronze and Silver policies and only 20% in Gold and Platinum. That’s comforting for adverse selection. A higher proportion of enrollment in the more generous plans would have been a warning sign that enrollment was coming disproportionately from the sick.

There’s a footnote on this point later on — we are not out of the woods — but this is definitely better news for the ACA than a distribution of, say, only 50% Bronze and Silver purchases.

The bad news

Just because the ACA is doing better than some had forecast on an overall basis does not mean there will not be very serious problems in some states.  Given that the statute is presently unamendable as a practical matter, problems in just a few states can hurt a lot of people.

The data released by HHS yesterday shows that there are a number of states in serious trouble.

Continue reading “New Data on ACA Enrollment Shows Problems in Many States”

By Josh Tenzer

While there has been much focus lately on the ways in which ObamaCare is chilling the growth of private business, we should not overlook the continuing deleterious effects of the one surviving relic of HillaryCare, the Health Insurance Portability and Accountability Act (HIPAA). Quietly, September 23 came and went as the compliance effective date for a new rule, expanding the reach of HIPAA, and likely driving many smaller players out of the health care industry.

Spearheaded by then First Lady Clinton, HIPAA was established in 1996 to improve privacy of personal health information, referred to as protected health information, or PHI. It requires health care providers, known as “covered entities,” and their vendors, contractors, and agents with access to PHI, known as “business associates,” to comply with certain privacy standards under its “Privacy Rule,” and with certain security standards under its “Security Rule,” in order to protect sensitive health information that is held or transferred in electronic form.

Over the past decade, equipped with the noble aim of protecting our privacy, HIPAA has successfully demonstrated the power of the law of unintended consequences. Improved protection of PHI has been marginal. However, HIPAA has impeded communication among physicians, reduced physician time devoted to patient care, and deterred medical research. And all at an enormous cost of compliance. While estimates vary widely, the cost of compliance for many providers has been in the millions.

Now, rather than take heed, the government has decided to double down through expansion. Under the Health Information and Technology for Economic and Clinical Health Act (HITECH), a corollary of HIPAA, promulgated to create incentives to facilitate the development of healthcare information technology, the government has sought to update the requirements of HIPAA in light of the changing dynamics of technology and health practices, increasing the safeguards and obligations of health care providers and their business associates.

Continue reading “Another Law Raising the Cost of Health Care”

By John Hudak

As Congress begins investigations into the Affordable Care Act rollout and the healthcare.gov flaws, Republicans are calling for resignations as far up as the Secretary of Health and Human Services. The logic goes: if managerial issues were behind failures to test the website component of the federal health care exchange, we need new management.

That concern is a valid one. In the private sector and often times in the public sector, when misakes happen—particularly in an area critical to the executive’s interests—heads roll.

Yet, Kathleen Sebelius will stay, and Republicans have no one to blame but themselves.

Why is this? In an ironic twist of fate the Republican Party’s obsession with filibustering, delaying, or holding executive branch nominations will finally have negative consequences for the GOP instead of the president.

Over the past several years, Republicans in Congress had refused to confirm a director of the Consumer Financial Protection Bureau because they did not like the law that authorized the agency. They refused to confirm nominees to the National Labor Relations Board because of opposition to unions. They put a hold on the chairman of the Federal Communications Commission for fear he may require more transparency in campaign activity. The examples go on.

Why, then, would President Obama remove Secretary Sebelius and nominate a replacement? The HHS Secretary oversees the implementation of the Affordable Care Act. And GOP opposition to CFPB or NLRB or FCC pales in comparison to the visceral and existential contempt the party feels toward Obamacare. Given such opposition, the president would be foolish to make such a change in HHS leadership.

Continue reading “Should Sebelius Resign?”

By Robert Laszewski

My sense is that the biggest reason Obamacare is now in trouble is because of the top-secret way in which the administration has handled the rollout. If they had developed the computer system in a transparent way, the marketplace would have told them long ago this would not work.

No one outside the inner circle at the Department of Health and Human Services has any idea what’s really going on behind the Wizard’s curtain. Hasn’t for months. Doesn’t now.

So any technical advice any of us could give would be, to say the least, uninformed.

If I were on the inside, and it were up to me, the first thing I would do is bring in a group of heavyweight information technology experts to tell me just what was really going on. The administration cannot trust the people who have been working on this because they told them to launch this mess on October 1 and almost three weeks in there has been no improvement on the website or in the backroom––they no longer have credibility.

I would ask those experts to very quickly answer three questions:

1. Can this thing be fixed on the fly––as the administration appears to be trying to do?
2. If it can’t be fixed on the fly––and three weeks into this that sure looks doubtful––then can it be taken down for one or two months with a high degree of confidence it can be brought back up in time to enroll people sooner rather than later?
3. If the first two options are not possible, just how long will the computer system have to be shutdown before Obamacare can be launched in a way that there can be confidence it will work smoothly?

Then I would take their advice.

Continue reading “Should the Obamacare Exchanges Be Shut Down?”

By THCBist

The U.S. government shutdown continues to claim victims.

The latest is HealthIT.gov, the website designed to help doctors and hospitals make the transition to electronic and make better use of health information technology – a key component of Obamacare’s drive to transform healthcare.

The Health Information Technology Office of the National Coordinator posted a brief announcement on the site informing visitors to HealthIT.gov that “information … may not be up to date, transactions submitted via the website may not be processed and the agency may not be able to respond to inquiries until appropriations have been enacted.”

Officials also sent a tweet saying that the ONC regrets to inform us that while the shutdown continues it will “not tweet or respond to tweets.”

This struck THCBist as slightly odd.

After all, if you’re looking for an inexpensive way to communicate with the public in a pinch, Twitter seems like the perfect choice.  We get that government websites are ridiculously expensive things to run. Blogs are considerably cheaper.  Operating a Twitter account — on the other hand — is almost free.  Our brains were flooded with scenarios.  How much could the ONC possibly be spending on Twitter? And for that matter, didn’t the Department of Defense originally invent the Internet to allow for  emergency communication during times of national crisis? Doesn’t a fiscal insurrection by cranky Republicans qualify?

Fallout for the National Health IT Program

While federal officials have issued repeated assurances that the shutdown will not impact the Obamacare rollout, it does look as though there will be a fairly serious impact on the administration’s health IT program.  If HHS sticks to script, only 4 of 184 ONC employees will remain on duty during the shutdown. That makes it sound like activities are going to have to be scaled back just a bit.

If you’re counting on getting an incentive payment from the government for participation in the electronic medical records program, you may be in trouble — at least until the stalemate is settled.  Although ONC has not yet made an official statement,  presumably because the aforementioned Twitter channel has been disabled, leaving the agency unable to speak to or otherwise communicate with the public, going by the available information in the thirteen-page contingency plan drafted by strategists at HHS, it is unclear where the money will come from.

This could be bad news for electronic medical records vendors counting on the incentive program to drive sales as the Obamacare rollout gets officially underway.

Continue reading “Washington In Crisis: ONC Announces That It Will Not Tweet Or Respond to Tweets During Shutdown”

By Adrian Gropper, MD

Health IT Week demonstrated a double barrel strategy to segregate patient information from provider information. Providers already have the power to set prices and health IT plays the central role.

By rebranding HIPAA as “Meaningful Consent” and making patients second-class citizens in Meaningful Use Stage 2 interoperability, providers and regulators are working together to keep it that way.

Essential consumer protections such as price transparency or independent decision support are scarce in the US healthcare system. The journalists are shouting from the rooftops.

There’s  $1 Trillion (yes, $3,000 per person per year) of unwarranted and overpriced health services steering the Federal health IT bus with an information asymmetry strategy. Those of us that want to see universal coverage succeed need the information transparency tools to drive for changes.

Here’s how it works: The department of Health and Human Services (HHS) controls the health IT incentives and regulations. HIPAA applies to most licensed health services providers. Laboratories and devices are regulated by Medicare and the FDA.

Unlicensed services offered directly to patients, such as personal health records, web info sites and apps are regulated by the FTC. Separate regulatory domains facilitate the segregation of information and contribute to the lack of transparency by making patient-directed services use delayed and degraded information. This keeps independent advice from FTC-regulated service providers from illuminating the specific abuses.

The segregation of patient information from “provider” information is the current federal regulatory strategy. It’s even more so in the states. By making patients into second-class citizens, the providers can avoid open scrutiny, transparent pricing, and independent decision support.

Federal regulators then create a parallel system where information is delayed, diluted, and depreciated by lack of “authenticity”. This is promoted as “patient engagement”. For regulators, it’s a win-win solution: the providers support the regulation that enables their price fixing and many patient advocates get to swoon over patient engagement efforts.

The proof of this strategy became clear on the first day of Health IT Week – the Consumer Health IT Summit.

Continue reading “A Troubling Strategy at Health IT Week”