The Border Is a Back Door for U.S. Device Searches

Newly released documents reveal how the government uses border crossings to seize and examine travelers’ electronic devices instead of obtaining a search warrant to gain access to the data.

The documents detail what until now has been a largely secretive process that enables the government to create a travel alert for a person, who may not be a suspect in an investigation, then detain that individual at a border crossing and confiscate or copy any electronic devices that person is carrying.

To critics, the documents show how the government can avert Americans’ constitutional protections against unreasonable search and seizure, but the confiscations have largely been allowed by courts as a tool to battle illegal activities like drug smuggling, child pornography and terrorism.

The documents were turned over to David House, a fund-raiser for the legal defense of Chelsea Manning, formerly known as Pfc. Bradley Manning, as part of a legal settlement with the Department of Homeland Security. Mr. House had sued the agency after his laptop, camera, thumb drive and cellphone were seized when he returned from a trip to Mexico in November 2010. The data from the devices was then examined over seven months.

Although government investigators had questioned Mr. House about his association with Private Manning in the months before his trip to Mexico, he said no one asked to search his computer or mentioned seeking a warrant to do so. After seizing his devices, immigration authorities sent a copy of Mr. House’s data to the Army Criminal Investigation Command, which conducted the detailed search of his files. No evidence of any crime was found, the documents say.

“Americans crossing the border are being searched and their digital media is being seized in the hopes that the government will find something to have them convicted,” Mr. House said. “I think it’s important for business travelers and people who consider themselves politically inclined to know what dangers they now face in a country where they have no real guarantee of privacy at the border.”

A spokeswoman from Customs and Border Protection said the agency declined to comment about the settlement with Mr. House, or answer questions about travelers’ rights when their devices are seized or inspected during a border crossing.

While many travelers have no idea why they are singled out for a more intrusive screening at a border, one of the documents released in Mr. House’s settlement shows that he was flagged for a device search months before he traveled to Mexico.

On July 8, 2010, Immigration and Customs Enforcement investigators in New York created an alert, known as a TECS lookout, for Mr. House, noting that he was “wanted for questioning re leak of classified material” and ordering border agents to “secure digital media” if he appeared at an inspection point.

TECS is a computer system used to screen travelers at the border, and includes records from law enforcement, immigration and antiterrorism databases. A report from the Department of Homeland Security about border searches of electronic devices says a traveler may be searched “because he is the subject of, or person-of-interest-in, an ongoing law enforcement investigation and was flagged by a law enforcement ‘lookout’ ” in the Immigration and Customs Enforcement computer system.

On Oct. 26, 2010, an automated message notified investigators that Mr. House had an airline reservation on Oct. 30, traveling on American Airlines flight 865 from Dallas-Fort Worth to Los Cabos, Mexico; a later query noted that he would be returning to Chicago O’Hare on American flight 228, landing at 6 p.m. on Nov. 3.

Since airline passengers are required to provide carriers with their birth date and passport number before a flight to or from the United States, and airlines pass that information to Homeland Security (as part of the Advance Passenger Information System), computers matched the lookout alert with Mr. House’s itinerary. Agents were then dispatched to meet him.

Technophoria: Dissent Over a Device to Help Find Melanoma

Ms. Oppel is a medical assistant in Manhattan in the office of Dr. Doris Day, one of the first dermatologists to buy the machine. Developed by Mela Sciences of Irvington, N.Y., the system uses pattern-recognition algorithms to help a dermatologist who has picked out a suspicious pigmented spot to decide whether to perform a biopsy. The device may find an audience among sun-seekers worried about developing an aggressive skin cancer: the National Cancer Institute estimates that about 9,500 Americans this year will die of melanoma of the skin.

Yet the device is polarizing the field of skin-cancer detection.

For decades, dermatologists have used their eyes, along with a magnifier called a dermatoscope, to try to distinguish abnormal but benign lesions from potential melanoma in order to avoid unneeded biopsies. Some dermatologists argue that these low-tech tools are still the most useful and worry that their colleagues are falling for expensive, cool-looking gadgets that may simply offer extraneous, and perhaps incorrect, data.

“This technology should still be considered to be in the developmental stage,” said Dr. Roberta Lucas, an instructor of clinical dermatology at the Northwestern University Feinberg School of Medicine in Chicago. “We are better off when the system supports doctors who are thorough and unhurried; who examine and listen carefully and who empower patients to practice good surveillance and sun protection.”

In fact, some members of an expert medical panel asked to review MelaFind a few years ago for the Food and Drug Administration warned that the device had the potential to give doctors and patients a false sense of security. While MelaFind can analyze small pigmented spots identified by dermatologists as having signs of melanoma, it is not designed to evaluate other problems: large melanomas, colorless melanomas or two other types of skin cancer — basal and squamous cell carcinoma.

Dr. Amy E. Newburger, a dermatologist in Scarsdale, N.Y., who was a member of that F.D.A. panel, told me that she was concerned that a doctor could inadvertently use MelaFind on a non-melanoma skin cancer, receive a score indicating that the spot was not irregular, and erroneously decide not to biopsy it. She voted against recommending the device for F.D.A. approval.

Some biostatisticians are also critical of MelaFind, saying the device can recognize a high percentage of melanomas correctly because it also falsely scores as positive so many non-melanomas — potentially prompting doctors to perform unnecessary biopsies.

To help me visualize that issue, Jason Connor, a biostatistician at Berry Consultants, a biostatistics consulting firm, compared the accuracy of MelaFind in distinguishing non-melanomas to a hypothetical pregnancy test which, used on 100 nonpregnant women, would mistakenly conclude that 90 of them were pregnant.

“My concern with MelaFind is that it just says everything is positive,” Mr. Connor said. A member of the F.D.A. panel, he abstained on a vote about whether the device’s intended uses outweighed the risks.

“I don’t think this helps an aggressive doctor,” Mr. Connor told me, “and unaggressive doctors could do just as well if they were more diligent without the device.”

To develop MelaFind’s current algorithm, researchers trained the system on digital images of more than 10,000 pigmented lesions, programming it to recognize irregularities like asymmetry, color variability and cellular disorganization characteristic of melanomas. Company executives said Mela Sciences deliberately calibrated the machine to catch as many melanomas as possible, understanding that such a high setting could lead doctors to biopsy normal tissue.

“It will err on the side of caution,” said Claudia Beqaj, director of commercialization at Mela Sciences. “We wanted to set the system to have such a high sensitivity that we didn’t miss any melanomas.”

(In a company-financed study submitted to the F.D.A., the device missed two out of 127 evaluable melanomas. One F.D.A. reviewer concluded: “There is inadequate data to determine any true value added for MelaFind for use by a dermatologist or other provider.”)

Ms. Beqaj emphasized that MelaFind was intended as a supplementary test that provided extra information about a mole, not as a substitute for a dermatologist’s own expertise.

“If they blindly followed MelaFind, they would be biopsying more," Ms. Beqaj said. “The doctor has to make their own clinical judgment.”

Dr. Day finds the system quite informative. Last week, she gave me a demonstration in her office on the Upper East Side of Manhattan.

Dr. Day picked out what she called an “ugly duckling” mole on the left arm of Ms. Oppel, who had kindly agreed to play the role of patient. Another medical assistant removed a hand-held scanner from the MelaFind console and pressed it against the mole.

Technophoria: Dissent Over a Device to Help Find Melanoma

Ms. Oppel is a medical assistant in Manhattan in the office of Dr. Doris Day, one of the first dermatologists to buy the machine. Developed by Mela Sciences of Irvington, N.Y., the system uses pattern-recognition algorithms to help a dermatologist who has picked out a suspicious pigmented spot to decide whether to perform a biopsy. The device may find an audience among sun-seekers worried about developing an aggressive skin cancer: the National Cancer Institute estimates that about 9,500 Americans this year will die of melanoma of the skin.

Yet the device is polarizing the field of skin-cancer detection.

For decades, dermatologists have used their eyes, along with a magnifier called a dermatoscope, to try to distinguish abnormal but benign lesions from potential melanoma in order to avoid unneeded biopsies. Some dermatologists argue that these low-tech tools are still the most useful and worry that their colleagues are falling for expensive, cool-looking gadgets that may simply offer extraneous, and perhaps incorrect, data.

“This technology should still be considered to be in the developmental stage,” said Dr. Roberta Lucas, an instructor of clinical dermatology at the Northwestern University Feinberg School of Medicine in Chicago. “We are better off when the system supports doctors who are thorough and unhurried; who examine and listen carefully and who empower patients to practice good surveillance and sun protection.”

In fact, some members of an expert medical panel asked to review MelaFind a few years ago for the Food and Drug Administration warned that the device had the potential to give doctors and patients a false sense of security. While MelaFind can analyze small pigmented spots identified by dermatologists as having signs of melanoma, it is not designed to evaluate other problems: large melanomas, colorless melanomas or two other types of skin cancer — basal and squamous cell carcinoma.

Dr. Amy E. Newburger, a dermatologist in Scarsdale, N.Y., who was a member of that F.D.A. panel, told me that she was concerned that a doctor could inadvertently use MelaFind on a non-melanoma skin cancer, receive a score indicating that the spot was not irregular, and erroneously decide not to biopsy it. She voted against recommending the device for F.D.A. approval.

Some biostatisticians are also critical of MelaFind, saying the device can recognize a high percentage of melanomas correctly because it also falsely scores as positive so many non-melanomas — potentially prompting doctors to perform unnecessary biopsies.

To help me visualize that issue, Jason Connor, a biostatistician at Berry Consultants, a biostatistics consulting firm, compared the accuracy of MelaFind in distinguishing non-melanomas to a hypothetical pregnancy test which, used on 100 nonpregnant women, would mistakenly conclude that 90 of them were pregnant.

“My concern with MelaFind is that it just says everything is positive,” Mr. Connor said. A member of the F.D.A. panel, he abstained on a vote about whether the device’s intended uses outweighed the risks.

“I don’t think this helps an aggressive doctor,” Mr. Connor told me, “and unaggressive doctors could do just as well if they were more diligent without the device.”

To develop MelaFind’s current algorithm, researchers trained the system on digital images of more than 10,000 pigmented lesions, programming it to recognize irregularities like asymmetry, color variability and cellular disorganization characteristic of melanomas. Company executives said Mela Sciences deliberately calibrated the machine to catch as many melanomas as possible, understanding that such a high setting could lead doctors to biopsy normal tissue.

“It will err on the side of caution,” said Claudia Beqaj, director of commercialization at Mela Sciences. “We wanted to set the system to have such a high sensitivity that we didn’t miss any melanomas.”

(In a company-financed study submitted to the F.D.A., the device missed two out of 127 evaluable melanomas. One F.D.A. reviewer concluded: “There is inadequate data to determine any true value added for MelaFind for use by a dermatologist or other provider.”)

Ms. Beqaj emphasized that MelaFind was intended as a supplementary test that provided extra information about a mole, not as a substitute for a dermatologist’s own expertise.

“If they blindly followed MelaFind, they would be biopsying more," Ms. Beqaj said. “The doctor has to make their own clinical judgment.”

Dr. Day finds the system quite informative. Last week, she gave me a demonstration in her office on the Upper East Side of Manhattan.

Dr. Day picked out what she called an “ugly duckling” mole on the left arm of Ms. Oppel, who had kindly agreed to play the role of patient. Another medical assistant removed a hand-held scanner from the MelaFind console and pressed it against the mole.

Amazon Plans an Internet Video Device

The company is developing a television set-top box and has begun discussions with outside providers of content to distribute their video services to the device, according to three people briefed on the plan, who spoke on condition of anonymity because the Amazon product had not yet been announced and remained confidential.

Amazon is planning to introduce the set-top box in the fall, one of these people said.

Bloomberg Businessweek first reported news of Amazon plans on Wednesday.

Kinley Pearsall, an Amazon spokeswoman, declined to comment.

It was not immediately clear why Amazon would bother designing its own set-top box. The device will most likely showcase Amazon’s own online video offerings, which include Prime Instant Video, a Netflix-like subscription video service with more than 40,000 movies and television episodes that is included as part of Amazon’s broader Prime membership.

Among other benefits, Prime members, who pay $79 a year, get free two-day shipping on orders bought through Amazon’s site.

Amazon also offers a much broader library of video content, totaling 150,000 titles, that anyone, including people who aren’t Prime members, can buy and rent.

But Amazon’s video services are already available on hundreds of devices, many of which connect to television sets, like game consoles, digital video recorders and Blu-ray players. An app for using Amazon’s video service is even embedded in some television sets, including models from Sony, Panasonic and Samsung.

Although Amazon was an early entrant in the e-reader market with the Kindle, the company is late to the market for set-top boxes, where the incumbents include Apple’s Apple TV device and a family of products from Roku.

Amazon, though, has considerable strengths and has shown an aptitude for reinventing itself in new categories, like cloud computing and tablet computers. One media executive who has participated in discussions with Amazon about its set-top box said he thought the company’s standing as a top shopping destination would allow it to promote its new device and give it a strong chance of attracting an audience.

The company could use other creative techniques for getting its set-top box into more living rooms.

Michael Pachter, an analyst at Wedbush Securities, said one approach that could make sense was for Amazon to sell the device for $100 or less, about what Internet set-top boxes cost today, and to include a free year of its subscription video service.

At the end of the term, customers would have an incentive to sign up for Amazon Prime to continue receiving all of its membership benefits, including the video service. “I think this is a Trojan horse to get people to join Prime,” Mr. Pachter said.

Amy Chozick contributed reporting from New York.

New Misgivings About St. Jude’s Heart Device

The decision by Medtronic, the nation’s biggest producer of heart devices, raises more questions about the safety of the St. Jude component — an electrical wire that connects an implanted defibrillator to a patient’s heart — and about how executives of that company have responded to those issues.

St. Jude executives have repeatedly insisted the wire, or “lead,” known as the Durata, is safe. Asked about the new study, which was sponsored by Medtronic, a spokeswoman for St. Jude said in a statement that numerous studies and tests had demonstrated the safety of the insulating material used in the Durata.

“We do not rely on Medtronic to confirm the safety and reliability of material we use in our products,” the statement, by Amy Jo Meyer, said.

Shares of St. Jude fell more than 12 percent Wednesday, to $31.37, after the Food and Drug Administration released a plant inspection report that found significant problems in the company’s testing and oversight of the Durata. The stock price represented a three-year low.

The F.D.A. report, which raises the prospect of potential agency action against St. Jude, appears to be the latest misstep by company executives in dealing with questions from investors and doctors about the safety of the Durata and an earlier heart device lead called the Riata, which the company has recalled.

In October, St. Jude executives released the F.D.A. report as part of a filing with the Securities and Exchange Commission but blocked all references in it to the Durata. In taking the unusual action, the company stated that it believed the F.D.A. would make similar redactions when it released the report in response to a Freedom of Information Act request, but the agency did not do so.

Earlier this year, St. Jude’s chief executive, Daniel J. Starks, also publicly criticized a heart device expert, Dr. Robert G. Hauser, after he raised questions about the safety of the Riata and the Durata. Mr. Starks then sought to have a medical journal retract an article written by Dr. Hauser. The publication refused.

“It’s becoming increasingly difficult to defend Durata,” one Wall Street analyst, Lawrence Biegelsen of Wells Fargo Securities, wrote Wednesday in a note to investors in which he downgraded St. Jude stock to hold from buy. He added that the release of the full F.D.A. report was “likely to heighten concerns” among doctors about using the Durata lead.

The Medtronic-sponsored study at issue appeared in the November issue of a scientific journal, Macromolecules, which is published by the American Chemical Society, a professional group.

In it, researchers looked at the durability of two chemically related insulating materials. One material that St. Jude calls Optim is used in the Durata. Medtronic was interested in using the other material, called Pursil 35, in a new heart device lead it was developing. Both products belong to a class of materials known as silicone-based polyurethanes.

The products were developed by different companies in an effort to solve a longstanding problem. Over time, insulating materials used in implanted devices are broken down by bodily fluids, exposing them to possible electrical failure and even short circuits that can prevent a device, like a defibrillator, from working when needed to save a life.

Recent episodes involving failures of heart devices or their components have involved failures of the insulating materials used in them.

In the study, both Optim and Pursil 35 were exposed in laboratory tests to water and heating techniques aimed to accelerate aging of the materials. While the Pursil 35 material changed faster than Optim, both materials lost substantial strength in the tests, said Dr. Frank S. Bates, a professor at the University of Minnesota and a Medtronic consultant who was involved in the study.

A spokesman for Medtronic, Christopher Garland, said the study results led the company recently to cancel the development of a new lead that would have used Pursil 35 as an insulating material. St. Jude has an exclusive arrangement with the developer of Optim to use it in heart device leads. Mr. Garland said that Medtronic had also been looking at that material’s use in other kinds of medical devices.

He added that Medtronic was working with producers of both materials to find ways to resolve some of the problems detected in the laboratory study.

Dr. James Runt, a professor at Pennsylvania State University who is a St. Jude consultant, said that the Medtronic study struck him as an “outlier” because both internal St. Jude studies and external reviews had supported the durability of Optim.

Katie Thomas contributed reporting.