Healthcare Data Privacy

Hacking Group Attempts to Extort Funds from Cancer Services Provider

Posted by HIPAA Journal

TheDarkOverlord has struck again, this time the victim was a small Indiana cancer charity. The attack occurred on January 11 and was accompanied with a 50 Bitcoin ($43,000) ransom demand. Little Red Door Cancer Services of East Central Indiana was threatened with the publication of confidential data if the ransom was not paid.

The charitable organization provides a range of services to help victims of cancer live normal lives during treatment, recovery, and at end of life. Little Red Door provides an invaluable service to cancer patients in East Central Indiana, with its limited funds carefully spent to provide the maximum benefit to cancer patients and their families.

The payment of a $43,000 ransom would have had a significant impact on the good work the organization does, and would have taken funding away from the people who need it most. Little Red Door followed the advice of the FBI and refused to pay.

Little Red Door spokesperson, Aimee Fant, issued a statement saying the organization “will not pay a ransom when all funds raised must instead go to serving families, all stage cancer clients, late stage care/hospice support and preventative screenings.”

The ransom demand was first sent to company executives, its vice president and president by text message. Messages were sent to their personal cell phones. The ransom demand and threats were also followed with email demands. The ransom demand was later reduced to around $12,000, although payment will still not be made. The stolen data included documents pertaining to grants, donors, employees, and the organization’s operations.

In addition to threatening to publish the data, TheDarkOverlord allegedly also issued a threat to contact the families of cancer patients, as well as the organization’s partners and donors.

Previous attacks by TheDarkOverlord have involved data theft. This time around, data were stolen and the company’s database and physical backups were wiped. Fortunately, patient diagnoses and other client information were on paper files.

Little Red Door has a cloud storage backup containing most of its data. Systems and databases will be rebuilt and data reconstructed. The cancer agency expects its IT systems to be back up and running by the end of this week. After recovery, Little Red Door will fully transition to a cloud-based system.

Little Red Door has received assistance from a number of organizations. A spokesperson for the organization said it “extends its immense gratitude to all who have helped in its efforts to gain control of the ransom attack and sincerely apologizes for any inconvenience and distress experienced on account of this act of cyberterrorism.”

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Protenus Releases 2016 Healthcare Data Breach Report

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Protenus, in conjunction with Databreaches.net, has published its 2016 healthcare data breach report, summarizing the hacks and mishaps that have resulted in patient and health plan members’ protected health information being exposed or stolen.

Fortunately, 2016 has not seen the mega data breaches of 2015, although it has been far from a good year. More than 27 million healthcare records were stolen in 2016 across 450 reported data breaches. The total number of breached records may be down year on year, but the total number of incidents has increased. 2016 has been the worst year for healthcare industry breaches since records first started being kept.

The Protenus 2016 healthcare data breach report includes data breaches that have already been reported to the Department of Health and Human Services’ Office for Civil Rights, in addition to those that have been disclosed to the media but not yet uploaded to the OCR breach portal.

In total, there were 27,314,647 individuals affected by healthcare data breaches in 2016, with detailed information available for 380 of the 450 incidents. More than one healthcare data breach was reported every single day, on average, in 2016.

Data breaches fluctuated throughout 2016, with no clear trend emerging. The worst months of the year – in terms of the number of records breached – were June and August. In June, 10,880,605 healthcare records were exposed or stolen. 9,096,515 records were breached in August.

The worst months of 2016 for reported data breaches were November (58 incidents) April (946 incidents) and August (45 incidents). January saw the fewest breaches with 21 incidents reported. January also saw the lowest number of healthcare records exposed, with 104,056 individuals impacted.

Million-record plus data breaches were relatively rare. The largest breach of the year – at Banner Health – saw 3.62 million records exposed.

The 2016 healthcare data breach report shows the majority of security breaches in 2016 involved insiders. Protenus classified insider breaches as those involving accidents caused by human error, data theft by healthcare workers, and snooping on medical records. 43% of the data breaches in 2016 involved insiders, compared to 26.8% of incidents which involved hacking, malware or ransomware.

There were 99 accidental data breaches and 91 breaches caused by insider wrongdoing. Breaches that were the result of insider wrongdoing tended to result in the theft of less data than accidental data breaches. Accidental data breaches exposed three times as many records, on average.

2016 saw an explosion in ransomware attacks with the healthcare industry heavily targeted. The healthcare data breach report indicates only 30 ransomware attacks were reported in 2016. The true figure may be considerably higher. Healthcare organizations are only required to report ransomware attacks if there was a reasonable probability that ePHI was compromised. Covered entities also have up to 60 days to report healthcare data breaches, so a final total for the year will not be available until March 1, 2017. 2016 also saw a rise in other extortion attempts, with hackers gaining access to healthcare data and demanding ransoms not to publish the information.

Hacking may not have been the biggest cause of healthcare data breaches in 2016, but hackers certainly obtained the most records. 120 hacking incidents were included in the report, although the number of records stolen in those attacks was only known for 99 incidents. Even so, the total number of records obtained by hackers was 87% of the annual total – 23,695,069 records.

Healthcare providers were the worst hit in 2016 accounting for 80% of the total breach count. Health plans were second with 10% of attacks, followed by business associate breaches which accounted for 6.3% of the total. 4% of breaches affected other entities.

The report shows healthcare organizations are slow to detect breaches. The report indicates the average time to discover data breaches was 233 days, although insider breaches took considerably longer. Cases of insider wrongdoing took an average of 607 days to discover that ePHI had been breached. Protenus reports the average time from the breach to reporting the incident to HHS was 344 days.

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Final Rule Updating Common Rule Regulations Issued by HHS

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The Department of Health and Human Services has published its Final Common Rule (45 CFR part 46). The Final Rule makes considerable changes to the Common Rule, although some of the most controversial elements which were included in September 2015 proposed rule have been dropped.

One of the proposed changes would have made it much harder for research organizations to use biomedical samples for research. Rather than allowing a general consent form to be used, HHS proposed that written consent be obtained from patients prior to their samples being used for further studies, requiring additional consent to be obtained from the patient in writing for every step of research.

If a tissue or blood sample was left over from a previous research study, additional written consent would have been required before that sample could be used, even when consent to use the sample for research had already been obtained from the patient in the first place.

The proposed change was included following a high-profile case of a woman – Henrietta Lacks – whose cancer cells were used in multiple research studies without her knowledge or consent. While the proposed change was important for patient privacy, it would have been a major headache that could have slowed research and reduced the number of tissue samples that could be used for essential biomedical research.

The proposed change attracted a huge number of negative comments (more than 2,100) from researchers  who felt it would slow their research. Additionally, there were cost considerations. The change would have made it difficult for small hospitals to provide samples for research due to the costs involved.

After reviewing the comments, the HHS decided to drop the change for the Final Rule. Now, samples can be used for research without obtaining additional consent from the donor of the sample, provided the samples are de-identified by removing names and other identifying information. Essentially, research can continue to be conducted as it currently is.

Another proposed change that attracted considerable criticism was the need for all researchers who received federal funding for clinical research to abide by the Common Rule. Critics pointed out that this requirement would not tackle the biggest problem – organizations that received no federal funding. It was believed that the change would also have hampered student research and social studies. This change was also dropped from the Final Rule.

When the Final Rule comes into effect, consent forms will need to include a concise summary at the start of the document explaining the most important information that potential research participants will need to know to give informed consent. The summary will need to include alternate treatments, and the risks and benefits of participation. Consent forms for certain federally funded programs will also need to be posted on public websites.

One controversial change that has not been dropped is the requirement for a single institutional review board (IRB) to be used for multi-institutional research studies to streamline oversight. However, a number of exceptions have now been included in the Final Rule to add greater flexibility.

The HHS says the Final Rule strengthens patient privacy protections while reducing the administrative burden on research institutions.

The changes were required because the Common Rule became effective in 1991 when most research was conducted at single sites by universities and medical institutions. However, today, the landscape is very different. Studies are now commonly spread across multiple institutions now that data have been digitalized. Large scale studies are now commonplace.

Jerry Menikoff, MD, Director of the HHS Office for Human Research Protections, said “We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants.

The 543-page Final Rule, which was produced with assistance from 15 federal agencies, will be effective from 2018.

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No HIPAA Violation Fine for Virginia State Senator

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While campaigning to become Republican state senator for Virginia in 2015, Henrico County physician Siobhan Dunnavant, M.D., used patients’ contact information – classed as protected health information under HIPAA Rules – to solicit donations from patients to help fund her campaign.

Contact information – names and addresses – was shared with her campaign team and was used to communicate with patients. The same information was also disclosed to a direct mail company: A violation of the HIPAA Privacy Rule. At least two complaints were received by the Department of Health and Human Services’ Office for Civil Rights about the privacy violation last year.

An OCR regional office contacted Dunnavant after being alerted to the privacy violation and informed her that her actions constituted an impermissible use and disclosure of PHI – violations of the HIPAA Privacy Rule.  Such violations can result in financial penalties being issued.

Dunnavant, who was later elect to the state senate, could have been fined up to $250,000 for the HIPAA violation and could potentially have been imprisoned for up to 10 years. However, OCR has chosen not to take further action.

No financial penalty was deemed appropriate as Dunnavant took immediate action to minimize damage. The investigation into the HIPAA violations has now been closed.

HIPAA violations are not always punishable with civil monetary penalties and do not always require resolution agreements. OCR prefers to resolve HIPAA violations through voluntary compliance and by issuing technical assistance. Civil monetary penalties and resolution agreements are typically reserved for the most serious violations of HIPAA Rules.

While Dunnavant’s use of patient contact information to solicit contributions did violate HIPAA Rules, the privacy violation was relatively minor and no patients came to harm as a result. Dunnavan believed her actions were permitted under HIPAA Rules as she had obtained a business associate agreement prior to disclosing the information.

Senator Dunnavant told the Richmond-Times Dispatch that the mailings were intended to advise patients of her political activity and reassure them that it would not have an impact on the provision of medical services. Dunnavant said she sought advice from her lawyers and medical practice board before sending the letter and no HIPAA issues were raised.  She also said she regretted adding an appeal for political support to the letters.

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HHS Issues Final Rule on Confidentiality of Alcohol and Drug Abuse Patient Records Regulations

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In February 2016, the Department of Health and Human Services published a proposed change to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations, (42 CFR Part 2) to facilitate health integration and information exchange. HHS has now finalized the Part 2 changes following an extensive evaluation of public comments, according to a recent press release from the Substance Abuse and Mental Health Services Administration (SAMHSA).

The Confidentiality of Alcohol and Drug Abuse Patient Records regulations were introduced in 1975 to protect the privacy of patients receiving treatment for substance abuse and mental health disorders. At the time there was concern that the revelation of patients’ identities would have serious social consequences and a lack of privacy may deter individuals from seeking treatment.

The healthcare delivery system has changed considerably during the past 40 years and Part 2 regulations were in need of modernization. While the privacy of patients must and will still be protected, the Part 2 changes will help to promote health integration and allow information exchange with research institutions.

According to HHS Deputy Assistant Secretary, Kana Enomoto, the Part 2 changes “will further enhance health services research, integrated treatment, quality assurance and health information exchange activities while at the same time safeguarding the essential privacy rights of people seeking treatment for substance use disorders.” Enomoto went on to explain that “These efforts clear the way for integrated health care models that can provide a better, more cost-effective health care system that also empowers people to make key decisions about their health care.”

A number of new provisions have been finalized in the HHS Final Rule:

  • Any lawful holder of patient identifying information will be permitted to disclose Part 2 identifying information to qualified individuals for purposes of scientific research, provided the research meets certain regulatory requirements. The sharing of data will enable organizations to conduct essential research on substance use disorders. SAMHSA will also permit data linkages between data sets and data repositories holding Part 2 data, if certain regulatory requirements are met.
  • In certain circumstances, patients will be permitted to use general designations such as “My Treating Providers” when giving consent to share personal information. Patients are not required to agree to disclosures of their personal information, although by doing so they will be able to benefit from integrated healthcare systems. If patients do use the general disclosure designation, they can request a list of individuals and entities with whom their information has been shared.
  • Changes have been made that outline audit/evaluation procedures necessary to meet the requirements of CMS-regulated accountable care organization and other CMS-regulated organizations. The changes permit financial and quality assurance functions critical to ACOs and other healthcare organizations.
  • Part 2 has been updated to cover physical and electronic documentation
  • SAMHSA will develop additional sub-regulatory guidance on the finalized provisions and will monitor the implementation of the Final Rule.

HHS has also issued a Supplemental Notice of Proposed Rulemaking (SNPRM) and is seeking input and comments from the public on additional clarifications and suggestions on a number of new provisions including:

  • Clarifying and limiting the circumstances under which contractors, subcontractors and legal representatives of lawful holders of Part 2 data can receive information for payment and healthcare operations activities.
  • An abbreviated alternative statement for the notice to accompany disclosure.
  • The use of contractors, sub-contractors, and legal representatives by CMS-regulated entities to carry out audit and evaluation activities necessary to meet the requirements of a CMS-regulated program.

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OCR HIPAA Enforcement: Summary of 2016 HIPAA Settlements

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The Department of Health and Human Services’ Office for Civil Rights has stepped up its enforcement activities in recent years, and 2016 HIPAA settlements were at record levels. In total, payments of $22,855,300 were made to OCR in 2016 to resolve alleged HIPAA violations. Seven settlements were in excess of $1,500,000.

In 2016, OCR settled alleged HIPAA violations with 12 healthcare organizations. Last year also saw an Administrative Law Judge rule that civil monetary penalties previously imposed on a covered entity – Lincare Inc. – by OCR were lawful, bringing the total to thirteen for 2016. Lincare was only the second healthcare organization required to pay a civil monetary penalty for violations of the Health Insurance Portability and Accountability Act. All other organizations opted to settle with OCR voluntarily.

Financial penalties are not always appropriate. OCR prefers to settle potential HIPAA violations using non-punitive measures. Financial penalties are reserved for the most severe violations of HIPAA Rules, when widespread non-compliance is discovered, or in cases where healthcare organizations have blatantly disregarded HIPAA Rules.

While largescale breaches of PHI may warrant financial penalties and will have an impact on the final settlement amount, OCR has resorted to financial penalties when relatively few individuals have been impacted by healthcare data breaches. This year has seen two settlements with organizations for breaches that have impacted fewer than 500 individuals – New York Presbyterian Hospital and Catholic Health Care Services of the Archdiocese of Philadelphia – and one civil monetary penalty – Lincare Inc.

A summary of 2016 HIPAA settlements with the Office for Civil Rights is detailed in the table below:

 

Summary of 2016 HIPAA Settlements

 

Covered Entity Date Amount Breach that triggered OCR investigation Individuals impacted
University of Massachusetts Amherst (UMass) November, 2016 $650,000 Malware infection 1,670
St. Joseph Health October, 2016 $2,140,500 PHI made available through search engines 31,800
Care New England Health System September, 2016 $400,000 Loss of two unencrypted backup tapes 14,000
Advocate Health Care Network August, 2016 $5,550,000 Theft of desktop computers, loss of laptop, improper access of data at business associate 3,994,175 (combined total of three separate breaches)
University of Mississippi Medical Center July, 2016 $2,750,000 Unprotected network drive 10.,000
Oregon Health & Science University July, 2016 $2,700,000 Loss of unencrypted laptop / Storage on cloud server without BAA 4,361 (combined total of two breaches)
Catholic Health Care Services of the Archdiocese of Philadelphia June, 2016 $650,000

 

 Theft of mobile device 412 (Combined total)
New York Presbyterian Hospital

 

 April, 2016 $2,200,000 Filming of patients by TV crew Unconfirmed
Raleigh Orthopaedic Clinic, P.A. of North Carolina April, 2016 $750,000 Improper disclosure to business associate 17,300
Feinstein Institute for Medical Research March, 2016 $3,900,000 Improper disclosure of research participants’ PHI 13,000
North Memorial Health Care of Minnesota March, 2016 $1,550,000 Theft of laptop computer / Improper disclosure to business associate (discovered during investigation) 299,401
Complete P.T., Pool & Land Physical Therapy, Inc. February, 2016 $25,000 Improper disclosure of PHI (website testimonials) Unconfirmed
Lincare, Inc.

 

 February, 2016* $239,800 Improper disclosure (unprotected documents) 278

*Civil monetary penalty confirmed as lawful by an administrative law judge

 

The largest HIPAA settlement of 2016 –  and the largest HIPAA settlement ever agreed with a single covered entity – was announced in August. OCR agreed to settle potential HIPAA violations with Advocate Health Care Network for $5.5 million.

The previous largest HIPAA settlements were agreed with New York-Presbyterian Hospital and Columbia University after PHI was accidentally indexed by search engines. The two entities were required to pay OCR a total of $4.8 million, with $3.3 million covered by New York-Presbyterian Hospital and the remainder by Columbia University. The previous largest HIPAA settlement for a single entity was agreed with Cignet Health ($4.3 million) for denying 41 patients access to their health records.

2017 has started with an early settlement with Presence Health. The $475,000 settlement was solely based on delayed breach notifications – The first time that a settlement has been agreed solely for a HIPAA Breach Notification Rule violation.

Looking forward into 2017 and beyond, the future of HIPAA enforcement activities is unclear. The new administration may cut funding for OCR which would likely have an impact on HIPAA enforcement.

This year will see the completion of the long-delayed second round of HIPAA compliance audits, although it is unlikely that a permanent audit program will commence this year.

Last year, Jocelyn Samuels said OCR will remain “laser-focused on breaches occurring at health care entities,” and that OCR is committed to “maintain an effective enforcement program that addresses industry-wide noncompliance and provides corrective action to protect the greatest number of individuals.”

However, Jocelyn Samuels will be standing down as head of OCR and it is currently unclear who will take her place. While there are a number of suitable candidates for the position, incoming president Trump has a lot on his hands and the appointment of an OCR director is likely to be relatively low down the to do list. When a new OCR director is appointed, we may find that he/she has different priorities for the OCR’s budget.

What we can expect to see in 2017 is a continuation of enforcement actions that have already commenced. HIPAA breach investigations take time to conduct and settlements even longer. The 2016 HIPAA settlements are the result of data breach investigations that were conducted in 2012-2013. The dramatic increase in data breaches in 2014 – and HIPAA violations that caused those breaches – may well see 2017 become another record-breaking year for HIPAA settlements.

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Warning for Healthcare Organizations that use MongoDB Databases

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Over the course of the past two weeks, the number of organizations that have had their MongoDB databases accessed, copied, and deleted has been steadily growing.

Ethical Hacker Victor Gevers discovered in late December that many MondoDB databases had been left unprotected and were freely accessible over the Internet by unauthorized individuals. By January 6, he reported that 13 organizations had had their databases copied and deleted. In their place was a new database containing nothing but a ransom demand. The hacker responsible offered to return the data once a ransom payment had been made – in this case 0.2 Bitcoin ($175).

The number of affected organizations has rapidly increased over the past few days. Today, more than 32,000 organizations have been issued with ransom demands and have had their databases deleted, including Emory Healthcare.

Emory Healthcare is not the only U.S. healthcare organization to have left databases exposed. MacKeeper security researcher Chris Vickery has identified another potential healthcare victim. A database used by WAMC Sleep Clinic – which operates the website militarysleep.org – has also been left exposed.

The database, which contains 2GB of information, includes details of 1,200 veterans who suffer from sleep disorders and have registered with the Sleep Clinic. The database contains sensitive information such as veterans’ names, email addresses, home addresses, former rank in the military, and their history of use of the site. The database also contains chat logs of conversations between doctors and veterans. Those logs contain highly sensitive details of patients’ medical conditions.

As with other organizations that have left their MongoDB databases in the default configuration, information can be accessed by anyone who knows where to look. No login credentials are required. Databases can be accessed without the need for usernames or passwords or any authentication.

The problem affects organizations that are using older versions of MongoDB. MongoDB had, in previous versions, been set with unrestricted remote access turned on as default. While later versions of the database platform had this changed with remote access set to off in the default configuration, many organizations are still using older versions and not changed the configuration settings to prevent unrestricted data access.

Unfortunately, many individuals have started to access unprotected MongoDB databases and have deleted data and issued ransom demands. One well known organized ransomware gang has also got involved and is attempting to extort money from 21,000+ organizations.

While some of these ‘hackers’ have exfiltrated data prior to deleting databases, others have not. Ransom demands are being issued nonetheless, although since no copy of the data has been taken, recovery will be impossible even if a ransom payment is made.

Healthcare organizations that use MongoDB databases should ensure that their security settings are updated to prevent remote access by unauthorized individuals. Given the number of organizations already attacked, failure to do so is likely to result in data being hijacked, or worse, permanently deleted. Gevers suggests there are more than 99,000 organizations that have misconfigured MongoDB databases and are therefore at risk.

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Warning for Healthcare Organizations that use MongoDB Databases

Posted by HIPAA Journal

Over the course of the past two weeks, the number of organizations that have had their MongoDB databases accessed, copied, and deleted has been steadily growing.

Ethical Hacker Victor Gevers discovered in late December that many MondoDB databases had been left unprotected and were freely accessible over the Internet by unauthorized individuals. By January 6, he reported that 13 organizations had had their databases copied and deleted. In their place was a new database containing nothing but a ransom demand. The hacker responsible offered to return the data once a ransom payment had been made – in this case 0.2 Bitcoin ($175).

The number of affected organizations has rapidly increased over the past few days. Today, more than 32,000 organizations have been issued with ransom demands and have had their databases deleted, including Emory Healthcare.

Emory Healthcare is not the only U.S. healthcare organization to have left databases exposed. MacKeeper security researcher Chris Vickery has identified another potential healthcare victim. A database used by WAMC Sleep Clinic – which operates the website militarysleep.org – has also been left exposed.

The database, which contains 2GB of information, includes details of 1,200 veterans who suffer from sleep disorders and have registered with the Sleep Clinic. The database contains sensitive information such as veterans’ names, email addresses, home addresses, former rank in the military, and their history of use of the site. The database also contains chat logs of conversations between doctors and veterans. Those logs contain highly sensitive details of patients’ medical conditions.

As with other organizations that have left their MongoDB databases in the default configuration, information can be accessed by anyone who knows where to look. No login credentials are required. Databases can be accessed without the need for usernames or passwords or any authentication.

The problem affects organizations that are using older versions of MongoDB. MongoDB had, in previous versions, been set with unrestricted remote access turned on as default. While later versions of the database platform had this changed with remote access set to off in the default configuration, many organizations are still using older versions and not changed the configuration settings to prevent unrestricted data access.

Unfortunately, many individuals have started to access unprotected MongoDB databases and have deleted data and issued ransom demands. One well known organized ransomware gang has also got involved and is attempting to extort money from 21,000+ organizations.

While some of these ‘hackers’ have exfiltrated data prior to deleting databases, others have not. Ransom demands are being issued nonetheless, although since no copy of the data has been taken, recovery will be impossible even if a ransom payment is made.

Healthcare organizations that use MongoDB databases should ensure that their security settings are updated to prevent remote access by unauthorized individuals. Given the number of organizations already attacked, failure to do so is likely to result in data being hijacked, or worse, permanently deleted. Gevers suggests there are more than 99,000 organizations that have misconfigured MongoDB databases and are therefore at risk.

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FDA Confirms Muddy Waters’ Claims that St. Jude Medical Devices Can be Hacked

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The U.S. Food and Drug Administration (FDA) issued a safety communication Tuesday about cybersecurity flaws in certain St. Jude Medical cardiac devices and the Merlin@home transmitter after it was confirmed the devices could potentially be remotely accessed by unauthorized individuals.

The FDA confirmed that unauthorized users could “remotely access a patient’s RF-enabled implanted cardiac device by altering the Merlin@home Transmitter,” potentially causing patients to be harmed. The flaws would allow an attacker to deplete the battery on implanted devices, alter pacing, or trigger shocks.

The FDA confirmed that there have been no reported instances of the cybersecurity flaws being exploited to cause harm to patients to date and patients have been advised to continue using the devices as instructed by their healthcare providers.

A patch to address the flaws has been developed and will be automatically applied this week. However, in order for the Merlin@home device to receive the update it must be left plugged in and connected to the Merlin Network.

The cybersecurity vulnerabilities were discovered by researchers at MedSec as part of a study into cybersecurity measures used to protect implantable medical devices. MedSec passed on details of the research to Muddy Waters last summer. In August 2016, Muddy Waters published a report criticizing St. Jude Medical for allowing ‘stunning cybersecurity flaws’ to remain unaddressed in its Merlin@home system and its associated defibrillators and pacemakers. St. Jude Medical denied the claims and sued Muddy Waters for disseminating ‘false and misleading’ information.

However, since the revelations were made in August, Abbott Laboratories, which recently acquired St. Jude Medical in a $25 billion deal, has been conducting its own investigations into device security. Abbott Laboratories has worked closely with both the FDA and the Department of Homeland Security to ensure that its pacemakers, defibrillator devices, and their associated systems are adequately protected and access by unauthorized individuals is blocked. The FDA has reviewed the software patch and has confirmed that it addresses the “greatest risks” and reduces the potential for exploitation and patient harm.

Carson Block, founder of Muddy Waters, issued a statement about the FDA announcement saying it “reaffirms our belief that had we not gone public, St. Jude would not have remediated the vulnerabilities.” However, while critical security vulnerabilities have been addressed, Block said “the announced fixes do not appear to address many of the larger problems, including the existence of a universal code that could allow hackers to control the implants.”

In the safety communication, the FDA reminded consumers that “any medical device connected to a communications network (e.g. wi-fi, public or home Internet) may have cybersecurity vulnerabilities that could be exploited by unauthorized users.” The FDA went on to say “the increased use of wireless technology and software in medical devices, however, can also often offer safer, more efficient, convenient and timely health care delivery.”

Cybersecurity Guidance for Medical Device Manufacturers

In December 2016, the FDA published its final cybersecurity guidance for medical device manufacturers. The document details measures that medical device manufacturers should adopt to ensure post-market devices are routinely assessed for vulnerabilities that could be exploited by hackers. The FDA released guidance in 2014 covering pre-market submissions for the management of cybersecurity in medical devices.

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