Amidst the worldwide COVID-19 pandemic, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) is allowing healthcare providers to use technology that is non-HIPPA compliant.

HIPPA is the federal Health Insurance Portability and Accountability Act.  HIPPA regulations protect patients from having their private information disclosed by health care providers, or treated in a manner that puts the information at risk of being disclosed.

On Tuesday, March 17, 2020, the OCR announced, effective immediately, that it will exercise its “enforcement discretion” by not imposing penalties against healthcare providers for HIPAA-violations in certain telehealth circumstances.  Telehealth is the provision of medical services via remote methods, such as telephone or videochat. OCR will not impose penalties for HIPAA violations in the use of telehealth services, but only when used in good faith for treatment or diagnostic purpose. The service does not have to be directly related to COVID-19.  The healthcare provider may use a “non-public facing” (not available for public access) remote communication product if they would like to use audio or video communication technology.

Under the OCR’s notice, popular videochat apps such as the following may be used for telehealth, though they may violate HIPAA rules:

  • Apple FaceTime,
  • Facebook Messenger Video Chat,
  • Google Hangouts video,
  • Skype, or
  • Zoom

However, healthcare providers may not use:

  • Facebook Live
  • Twitch
  • TikTok
  • Or similar video communication apps that are “public facing”

Notwithstanding the relaxed rules, there are several vendors that represent they can provide healthcare video communication products through a HIPPA-compliant business association agreement. Some of these vendors are:

  • Skype for Business/Microsoft Teams
  • Updox
  • VSee
  • Zoom for Healthcare
  • Doxy.me
  • Google G Suite Hangouts Meet
  • Cisco Webex Meetings/Webex Teams
  • Amazon Chime
  • GoToMeeting

Allowing healthcare providers to continue to examine patients during the COVID-19 crisis, while limiting the risks of in-person exposure is a noble goal.  The obvious negative is that many of third-party communication apps, including those referenced by the OCR, pose privacy risks to the patient.  For the vast majority of us, the COVID-19 crisis will be over in due time.  But our personally-identifying information, such as our names, addresses, and social security numbers, is a lot more difficult to change. 

In our opinion, if a healthcare provider intends to utilize a non-HIPPA complaint communication vendor or application, that should be disclosed to the patient and their consent should be obtained – at a minimum. The patient should be informed prior to consenting that using the service may put their private information at risk.  The healthcare provider should take reasonable steps, no matter what particular service is being used, to enable available encryption and privacy protection settings, if available.  HIPAA-complaint vendors and technology should be the clinician’s first choice.

Find the OCR’s Notice here:  https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html

For additional information: https://www.hhs.gov/sites/default/files/telehealth-faqs-508.pdf

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Palomar Medical Center in San Diego has just announced that the personal information of 1,300 patients was breached by an employee.  The personal information includes, name, date of birth, gender, medical record number, diagnosis and other information.  Some patients have had their health insurance information, financial data, social security and driver’s license numbers accessed.

A news story reporting the breach is here.

If you received a notice from Palomar Medical Center of this data breach, or you believe that your medical records or personal information was disclosed without your permission, you may be entitled to compensation. Call our office at the number below to discuss your rights.

For further information on your rights when a hospital fails to protect your personal information, click here: JanMulligan.com:  Your Rights In Data Breach Cases.

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heading_departmentEight California hospitals were fined a total of $483,650 for serious issues in patient care, according to a report released Thursday.  The fines, levied by the California Department of Public Health, came after the Department’s investigations discovered non-compliance with licensing requirements which “caused, or was likely to cause, serious injury or death  to patients.” The fines ranged from $47,025 to $86,625 per hospital.

Administrative penalties are issued to hospitals under authority granted by California Health and Safety Code Section 1280.1. Newly adopted regulations allow the Department to assess an administrative penalty for incidents occurring on or after April 1, 2014, against a specified licensee for a deficiency constituting an “immediate jeopardy” violation up to a maximum of $75,000 for the first administrative penalty, up to $100,000 for the second, and up to $125,000 for the third and every subsequent violation within three years.

San Diego’s Vibra Hospital was among those fined.  Vibra was fined $47,025 in connection with a patient’s brain damage and death in 2014, attributed to staff ignoring signs and alarms that should have alerted them that a breathing ventilator had become disconnected, as reported by the San Diego Union Tribune.  A full report of the incident can be found on the Department of Public Health’s website.  The fine was noted as the hospital’s first “immediate jeopardy” administrative penalty since the program began. Vibra was also required to submit a “plan of correction” to California’s health regulators.

Licensing requirements exist to protect us from the increasingly consolidated, powerful, and for-profit medical industry.  As patient-advocates, and members of the community, we applaud these recent regulatory measures by the Department of Public Health.  At the same time, we question whether a $47,025 penalty for a preventable injury that ended a patient’s life sends a strong enough message of the value we place on patient safety.  Ultimately, it is not the amount of a single fine that will keep us safe. Safe care is brought about by long-term attention and support from consumers — and voters — for vigilant oversight of the medical industry.

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In 2012,  national news outlets broke a story about a malicious scam concerning counterfeit, implant hardware being used for spinal fusion surgeries in California hospitals. Pacific Hospital and Tri-City Hospital, both in the Long Beach area, were at the center of the allegations.

As of October 2014, lawsuits have reportedly been filed by over 30 former patients. Attorneys say thousands more patients may have been affected.

The allegations include an elaborate scheme involving bribes to doctors in exchange for referrals to these hospitals, and the manufacturing and use of non-FDA approved, counterfeit implant screws in the subsequent surgeries. Michael Drobot, the former owner of Pacific Hospital, is accused of personal involvement in the scheme.

The lawsuits maintain that the hospitals charged full price for the counterfeit screws, which were made at a fraction of the cost of FDA-approved hardware. The use of the allegedly inferior materials may have put the well-being of thousands of patients, in these southern California hospitals and elsewhere, at risk.

According to the state discharge data, there were 550 spinal fusions at Pacific and Tri-City alone in the last decade.

Click below to read more.

Wall Street Journal article:
http://online.wsj.com/articles/SB10001424052970204319004577088712149447348

Outpatient Surgery article:
http://www.outpatientsurgery.net/outpatient-surgery-news-and-trends/general-surgical-news-and-reports/california-hospitals-docs-accused-of-lucrative-spine-surgery-scam–10-21-14?utm_source=news&utm_medium=email&utm_campaign=tji

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This firm strongly supports the Pack Patient Safety Act, which will be on the November 2014 General Election Ballot.

The Act adjusts, for the first time in 39 years, the cap on damages in medical negligence cases. That cap, placed at the time of the initial legislation in 1975, was $250,000.00. It has stayed the same, without any adjustment for inflation, for nearly four decades. The cap is worth only $58,000.00 in today’s dollars.

The lack of any inflationary adjustment has had the impact of preventing people with very valid claims from pursuing justice.

The Act also requires, among other things, that doctors prescribing narcotics to a patient for the first time check a database to ensure that the patient is not doctor shopping.

You can read more about the Act here: https://www.facebook.com/38IsTooLate/timeline

Please join us in supporting patient safety and this very worthy legislation.

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Patients considering robotic surgery are not getting the full picture of its risks, according to a new investigative report from Bloomberg (“Unreported Robot Surgery Injuries Open Questions for FDA“).  Many “adverse events” — when something goes wrong — are never reported to the FDA, due to a deeply flawed reporting system.

“While a U.S. database lists reports of deaths and injuries sent to the Food and Drug Administration, the agency has no authority to force doctors to contribute. And while hospitals are supposed to report, they often don’t, critics say.”

“Every link in the chain has a reason not to report,” according to a source.

But surely, the FDA requires robots made to perform surgery to pass some test of safety and efficacy at some time, right?  Wrong.  Many medical devices, including many surgical robots, are not required to pass FDA “pre-market approval” testing prior to being used on patients.  Instead, they are “grandfathered” into the market through a loophole in the pre-market approval process.  A loophole which purportedly exists because the FDA lacks the resources to conduct testing or review data on every new product.

When clinical data on safety and efficacy is not required before the marketing of a new device, and adverse events are under-reported afterward, how can the FDA, hospitals or doctors make an informed decision on whether to use them — much less patients?

Bloomberg cites a plan announced by the FDA in September 2012 to improve its monitoring of medical devices, including working toward automated reporting of adverse events.  But the reforms are not coming quick enough for many critics.

“[The ultimate goal] is years away and still won’t address the training and marketing issues that have been spotlighted by the Intuitive [da Vinci surgical robot]. The FDA doesn’t regulate doctor training on devices or most hospital device marketing.”

We’ve blogged about the importance of doctor training on surgical robots before (“CUTTING EDGE MEDICINE AT ITS FINEST – THE 2012 UCSD PATIENT SAFETY CONFERENCE“). Experienced surgeons continue to put down their scalpels for joysticks.  Thankfully, some hospitals recognize the need for thorough training. But don’t think that the FDA requires it, approves it, or monitors it.

The robotic revolution is a sea change in surgical medicine that holds a lot of promise, a lot of risk, and deserves our full attention.  Unfortunately, we are looking at an incomplete picture, painted by those with an incentive to keep it rosy.

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The New York Times recently reported on a link between an increase in liver injuries over the past decade and the largely unregulated world of over-the-counter dietary supplements. According to this article, a shocking 70 percent of dietary supplement companies are not following basic quality control standards, in addition to other serious concerns.

Use caution when selecting and taking supplements. Herbal supplements in particular may appear more “natural” but can contain a highly concentrated amount of their active ingredient, at a level not found in nature. “[L]iver injuries attributed to herbal supplements are more likely to be severe and to result in liver transplants,” according to new research from the National Institutes of Health.

Seek guidance from your doctor on whether and what to take, and know your legal rights and limitations if something goes wrong.

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On July 31, 2012, the Missouri Supreme Court struck down a $350,000 cap on noneconomic damages (pain and suffering) in medical malpractice lawsuits.  The court held that the cap on damages violated a person’s constitutional right to trial by jury under the state constitution.  The complete text of the opinion can be found here.

Missouri now joins six other states that have held damage caps in medical malpractice actions unconstitutionally take a victim’s compensation of the hands of the jury.  Other states include Alabama, Georgia, Illinois, New Hampshire, Oregon and Washington.  California and six other states have challenges pending.  See an updated list here.

For more information, or if you or a loved one have been injured in California, please contact the experienced lawyers at Mulligan, Banham & Findley.  Our telephone number is 619-238-8700.

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Tomorrow, the U.S. House of Representatives will vote on H.R. 5, the deceptively-named “Protecting Access to Healthcare Act” (The PATH Act).  Unfortunately, it will pass.

Should this bill become law, it would “protect” at-fault healthcare providers, drug companies and their insurers from responsibility, by drastically limiting the rights of patients injured by medical malpractice, unsafe drugs, medical devices and nursing home care.  Among other broad “reforms,” H.R. 5 would establish a permanent $250,000 cap on non-economic damages (e.g., pain and suffering) on all medical negligence cases.

As we know too well in California, such damage caps can do the most harm to patients who have been injured the worst – those that have been permanently and catastrophically injured by the culpable conduct of their healthcare provider.  These patients can be compensated for their suffering no more than significantly less injured patients.  And when the risk of a large judgment is removed, so is a strong motive for the provider to use due care.

The Center for Justice and Democracy has written a compelling letter to the House against the bill, outlining the damages cap issue and other flaws; it is available Here.

This article in the Huffington Post describes the bill’s discriminatory impact on women.

The full text of H.R. 5 can be found Here.

The bill’s many flaws were no doubt exacerbated by its rush to the floor without thorough vetting.  But given the political mechanics of the House, it appears that there are simply not enough votes to defeat H.R. 5.  Still, it must pass the Senate in some form, and a strong opposition in the House could deprive the bill of momentum, and convince lawmakers to think take a second look at the bill before casting an “Aye.”

The Obama Administration’s official Statement of Administration Policy on H.R. 5 – released earlier today –  indicates that the President’s “senior advisors” would recommend a veto, should the bill pass both houses of the legislature.  The Administration takes particular issue with the bill’s egregious damages caps.  From the Administration’s Statement:

[T]he Administration has serious concerns with key aspects of medical malpractice provisions included in H.R. 5. The goals of medical malpractice reform should be to provide fair and prompt compensation to patients who have been harmed by medical negligence, reduce preventable injuries, improve the quality of care, reduce defensive medicine, and lower medical liability premiums. However, H.R. 5 would establish inappropriate and harmful restrictions on health care lawsuits without effectively meeting these goals. Specifically, the Administration opposes placing artificial caps on malpractice awards which will prevent patients and other claimants who have been wrongfully harmed from receiving just compensation.

Hopefully, the fight over H.R. 5 will not come so close as to require a presidential veto.  While the above statement is promising, the President himself has not yet taken a position.  Call your legislator.  Let them know that the way to reform healthcare is not to harm those wrongfully and significantly injured by those to whom they entrusted their health.  The phone number for the Capitol Switchboard is 202-224-3121.

Update:  H.R. 5 did pass the House 223 to 181.

For more information, or if you or a loved one have been injured in California, please contact the experienced lawyers at Mulligan, Banham & Findley. Our telephone number is 619-238-8700.

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